Sterilizable wirelessly detectable objects for use in medical procedures and methods of making same

ABSTRACT

Various embodiments of wirelessly detectable objects to be used in medical procedures are provided. Such may employ ionizing radiation hard wireless radio frequency identification (RFID) transponders, other wireless transponders and/or integrated circuits, and attachment structures, all of which retain structural and functional integrity when exposed to standard sterilization dosages of ionizing radiation. Additionally or alternatively, the wireless radio frequency identification (RFID) transponders, other wireless transponders and/or integrated circuits, and attachment structures, may retain structural and functional integrity when exposed to standard sterilization temperatures and/or pressures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a U.S. national stage application filed under 35U.S.C. § 371 of International Patent Application PCT/US2016/014335,accorded an international filing date of Jan. 21, 2016, which claims thebenefit of U.S. Provisional Patent Application Nos. 62/106,052 filedJan. 21, 2015; 62/138,248 filed Mar. 25, 2015; 62/164,412 filed May 20,2015; and 62/182,294 filed Jun. 19, 2015, which applications areincorporated herein by reference in their entirety.

BACKGROUND Technical Field

The present disclosure generally relates to medical procedure relatedobjects (e.g., sponges, instruments, tools, etc.) tagged with wirelesslyreadable wireless transponders.

Description of the Related Art

It is important to determine ascertain that objects associated withsurgery or other medical procedures (e.g., labor and delivery (L&D)) arenot present in a patient's body before completion of surgery or othermedical procedure to prevent unintended retention of what are consideredforeign objects with respect to the body. Such medical procedure objectsmay take a variety of forms. For example, the medical procedure objectsmay take the form of instruments or tools, for instance scalpels,scissors, forceps, hemostats, endoscopes, clips and/or clamps. Also forexample, the medical procedure objects may take the form of disposableor consumable objects, for instance surgical sponges, gauzes, and/orpads. Failure to locate a medical procedure object before completing themedical procedure (e.g., closing the incision or wound of the patient)may require additional medical procedures to retrieve the medicalprocedure object (e.g., additional surgeries) exposing the patient tofurther trauma, complications and inconvenience. In some instances,failure to locate a medical procedure object may have serious adversemedical consequences, for example due to an infection leading to sepsisand possible death. Additionally, failure to locate a medical procedureobject may also result in significant additional costs in providingmedical care.

Most hospitals and other clinical facilities have instituted proceduresthat employ checklists and/or require multiple manual counts to beperformed to determine the total number of medical procedure objects ata start of and at an end of a medical procedure. These processes may bedenominated as manual count-in/count-out or check-in/check-outprocesses, since they typically employ a manual counting at a start andan end of a medical procedure or checking in and checking out of themedical procedure objects. These manual approaches are inefficient,requiring the time of highly trained personnel, and are prone to error.

Another approach marks various objects with optically readablemachine-readable symbols, which each encode a respective uniqueidentifiers. These machine-readable symbols may take various forms, forinstance linear or one-dimensional machine-readable symbols, commonlyreferred to as barcode symbols, or two-dimensional symbols, typicallydenominated as area or matrix code symbols. The symbols may be encodedaccording to any of a large variety of symbologies (e.g., mappingsbetween machine-readable characters and human-readable characters). Theoptically readable symbols may be printed on respective tags or labels,which are attached to the respective medical procedure objects, forinstance via an adhesive. Symbols may alternatively be etched orotherwise inscribed on respective medical procedure objects. In use, amachine-readable symbol reader (e.g., barcode scanner) may illuminatethe machine-readable symbol and automatically read a unique identifierencoded therein. The process tends to mimic the manualcount-in/count-out or check-in/check-out processes, that is each item isscanned prior to or at the start of a medical procedure, and thenscanned again following or at the end of the medical procedure. Aprocessor-based device may perform an automated comparison, providing analert when the list of medical procedure objects at the end of themedical procedure does not match the list of medical procedure objectsat the start of the medical procedure.

Yet another approach marks various objects with wirelessly readabletransponders, each transponder encoding a respective unique identifier.These wirelessly readable transponders are commonly referred to as radiofrequency identification (RFID) tags or transponders, even though theRFID transponders may operate in the high radio frequency or evenmicrowave portions of the electromagnetic spectrum. These RFIDtransponders typically include a memory in the form of an integratedcircuit, for example a read/writable memory which can be read many timesand written too many times. Typically, RFID transponders are passivedevices, without a battery. These passive RFID transponders deriveelectrical energy from an interrogation signal transmitted by an RFIDreader or interrogator. The RFID transponders may be attached torespective ones of the medical procedure objects. In use, an RFID readeror interrogator emits a radio or microwave frequency signal. Inresponse, an RFID transponder that receives the interrogation signalcharges a capacitor, which provides sufficient power to return (e.g.,backscatter) a response signal that encodes the unique identifier storedin the RFID transponder. The interrogator receives the return signalidentifying the respective RFID transponder. The process tends to mimicthe manual count-in/count-out or check-in/check-out processes, that iseach item is scanned prior to or at the start of a medical procedure,and then scanned again following or at the end of the medical procedure.A processor-based device may perform an automated comparison, providingan alert when the list of medical procedure objects at the end of themedical procedure does not match the list of medical procedure objectsat the start of the medical procedure.

Another approach employs wirelessly detectable transponders and awireless detection system. This approach typically employs simple LCresonant wireless transponders, which do not encode or return any uniqueidentifying information, thus may be denominated as or “dumb” wirelesstransponders. These dumb wireless transponders that are attached tovarious medical procedure objects using a variety of structures (e.g.,adhesives, epoxy, potting material, housings). The wireless detectionsystem includes one or more radios, with a transmitter that emits pulsedwideband wireless excitation signals (e.g., radio or microwavefrequency) and a receiver or detector that detects wireless return orresponse signals returned by the dumb wireless transponders in responseto the emitted pulsed wideband signals. In use, the wireless detectionsystem scans a body or portion of a body of a patient for the presenceor absence of a dumb wireless transponder. Such an automated detectionsystem may operate at relatively low frequencies ranges, advantageouslyincreasing accuracy particularly where the dumb transponder may belocated in vivo (i.e., in bodily tissue) as compared to RFID basedapproaches. Such an automated detection system may also significantlyreduce the amount of time required of highly trained and highlycompensated personnel as compared to the previously describedapproaches. Some examples of the dumb transponder and wireless detectorapproach are discussed in U.S. Pat. No. 6,026,818, issued Feb. 22, 2000,and U.S. Patent Publication No. U.S. 2004/0250819, published Dec. 16,2004. The dumb transponder and wireless detector approach contrasts topreviously described approaches, since this approach does rely on thepreviously described count-in/count-out or check-in/check-out techniquescommon of the previously described approaches.

The medical procedure object must be sterilized prior to use in amedical procedure. Sterilization procedures typically take one or moreforms, including heating, pressurization, and/or exposure to ionizingradiation (e.g., Gamma radiation).

BRIEF SUMMARY

In any of the above-described approaches, anything attached to themedical procedure object (e.g., machine-readable symbol, RFID wirelesstransponder, dumb wireless transponder) must like-wise be capable ofundergoing sterilization procedures. However, sterilization proceduresmay have a damaging effect on integrated circuits, semiconductor-baseddevices and/or associated attachment structures (e.g., adhesives). Forexample, many integrated circuits or semiconductor-based devices (e.g.,memory) are adversely affected by exposure to Gamma radiation that mayrender data or information unreliable. Also, various adhesives orpolymers (e.g., plastics) are adversely affected by heat, pressure, acombination of heat and pressure, and/or ionizing radiation (e.g.,X-ray, Gamma ray radiation).

Consequently, new approaches, structures and techniques are desirable tofacilitate the marking of medical device objects and automated detectionof the same in bodily tissue and/or inventorying of the same for use inperforming medical procedures, and prevention of unintentional retentionof a foreign object retention in a body cavity or tissue.

The use of materials that can withstand sterilization may beadvantageous where a medical procedure object will undergo sterilizationprior to use, or may be subject to repeated sterilization procedures,for instance in preparation for reuse or repeated use for multipledifferent medical procedures.

A radiation hard (e.g., X-ray, Gamma ray radiation hard) RFIDtransponder, other wireless transponder and/or integrated circuit,particularly a radiation hard read-only (i.e., write once) memory, whichencodes a unique identifier, may be particularly useful in marking andidentifying medical procedure objects to be used during a medicalprocedure. Such may be used to mark durable or reusable or medicalprocedure objects, for instance medical instruments or tools, as well asto mark disposable or consumable medical procedure objects, for instancegauzes or sponges. Additionally or alternatively, the RFID transponder,other wireless transponder and/or integrated circuit may also becomposed of materials that withstand elevated heat or temperatures,elevated pressures, and/or combinations of elevated heat or temperaturesand pressures commonly experienced during sterilization procedures.

Optionally, a radiation hard integrated circuit may take the form of aradiation hard wireless RFID transponder with a radiation hard memorythat stores a unique identifier. The radiation hard wireless RFIDtransponder may preferably transmit and/or receive signals in arelatively low radio frequency range, below that of conventional RFIDtransponders.

It may be advantageous if attachment structures that attach RFIDtransponder, other wireless transponder and/or integrated circuits tomedical procedures objects are also radiation hard and/or composed ofmaterials that withstand elevated heat or temperatures, elevatedpressures, and/or combinations of elevated heat or temperatures andpressures commonly experienced during sterilization procedures.

In use on medical procedure sponges, the RFID transponder, otherwireless transponder or integrated circuit may be retained in a pouch.The pouch may be closed or sealed via a weld (e.g., heat weld, RF weld)and/or via one or more stitches (e.g., sewn thread), or via one or morestaples to retain the RFID transponder, other wireless transponderand/or integrated circuit in an interior of the pouch. The pouch may beattached to gauze or a sponge via a weld (e.g., heat weld, RF weld)and/or via one or more stitches. The pouch is preferably made of amaterial that withstands elevated temperatures, elevated pressures,and/or combinations of elevated temperatures and elevated pressurescommonly employed in sterilization of objects for use in medicalprocedures, for example sterilization of gauze or sponges. The pouch ispreferably made of a radiation hard material that withstands(essentially unaffected) by exposure to ionizing radiation (e.g., X-ray,Gamma ray radiation), particularly doses and durations of ionizingradiation employed in sterilization of objects for use in medicalprocedures, for example sterilization of gauze or sponges.

Likewise, material that closes or seals the pouch and/or that attachesthe pouch to the gauze or sponge, is preferably made of a material thatwithstands elevated temperatures, elevated pressures, and combinationsof elevated temperatures and elevated pressures commonly employed insterilization of objects for use in medical procedures, for examplesterilization of gauze or sponges. Likewise, material that closes orseals the pouch and/or that attaches the pouch to the gauze or sponge,is preferably made of a radiation hard material that withstands(essentially unaffected) by exposure to ionizing radiation (e.g., X-ray,Gamma ray radiation), particularly doses and durations of ionizingradiation employed in sterilization of objects for use in medicalprocedures, for example sterilization of gauze or sponges.

Gauze may be folded to position or space the pouch, RFID transponder,other wireless transponder and/or integrated circuit on one or moreinterior folds or portions of a plurality of folds or portions, inwardlyof a pair of outer-most folds, portions or layers of a sponge.

Sponges may optionally include one or more pieces of a radio-opaquematerial, to facilitate detection using medical imaging (e.g., ray-tech,X-ray). For example, one or more threads of radio-opaque material may bewoven, knitted or attached to the gauze at one, two or more distinctlocations. For instance, a first set of radio-opaque threads may extendacross a width of the gauze or sponge at a first location, and a secondset of radio-opaque threads may extend across the width of the gauze orsponge at a second location, spaced from the first location along alength of the gauze or sponge.

Gauze may be folded to position or space the radio-opaque material onone or more interior folds or portions of a plurality of folds orportions, inwardly of a pair of outer-most folds, portions or layers ofa sponge. Such may facilitate detection of closely spaced sponges, forexample when verifying a total number of sponges in a packet or packageof sponges, for instance during manufacturing or packaging.

On use on medical procedure instruments, the RFID transponder, otherwireless transponder or integrated circuit may be attached via a varietyof attachment structures. Attachment structures may, for example,include adhesive, epoxy or potting materials. The attachment structuresmay, for example, include one or more clamps, for instance with a springor other bias member, or with a fastener, for instance a threadedfastener, with or without a nut or similar member. The attachmentstructure may comprise a housing, which may clamp or otherwise attach tothe RFID transponder, other wireless transponder or integrated circuit.Where the medical procedure instrument is made of metal, the attachmentstructure may position the RFID transponder, other wireless transponderor integrated circuit at least or more 2 centimeters from metal.

The attachment structure is preferably made of a material thatwithstands elevated temperatures, elevated pressures, and/orcombinations of elevated temperatures and elevated pressures commonlyemployed in sterilization of objects for use in medical procedures, forexample sterilization of instruments or tools. The attachment structureis preferably made of a radiation hard material that withstands(essentially unaffected) by exposure to ionizing radiation (e.g., Gammaradiation), particularly doses and durations of ionizing radiationemployed in sterilization of objects for use in medical procedures, forexample sterilization of gauze or sponges.

Gauze and sponges, and associated pouches, RFID transponders, otherwireless transponders, and integrated circuits will typically undergo ona single sterilization procedure. In contrast, medical procedure toolsmay be used repeatedly in two or more medical procedures, going througha sterilization procedure prior to each medical procedure. Thus,materials intended for use with gauze or sponges might be less robustwith respect to the rigors experienced during sterilization as comparedto those used for durable medical tools (e.g., scalpel, forceps,clamps).

The various materials preferably retain structural and functionalintegrity when exposed to heat, pressure, combinations of heat andpressure, and/or ionizing radiation. As used herein, radiation hardrefers to any material that maintains its structural and functionalintegrity under dosages of radiation commonly used in sterilizing thatparticular medical procedure object to which the material is attached.

The various materials preferably retain structural and functionalintegrity at least at temperatures equal to 121 degrees Centigrade, ormore preferably at least at temperatures equal to 130 degreesCentigrade, or even more preferably at least at temperatures equal to136 degrees Centigrade, or most preferably at least at temperaturesequal to, or greater than, 150 degrees Centigrade.

The RFID transponder, other RF transponder and/or integrated circuitretains structural and functional integrity at least at temperaturesequal to 121 degrees Centigrade, or more preferably at least attemperatures equal to 130 degrees Centigrade, or even more preferably atleast at temperatures equal to 136 degrees Centigrade, or mostpreferably at least at temperatures equal to, or greater than, 150degrees Centigrade.

The attachment structure retains structural and functional integrity atleast at temperatures equal to 121 degrees Centigrade, or morepreferably at least at temperatures equal to 130 degrees Centigrade, oreven more preferably at least at temperatures equal to 136 degreesCentigrade, or most preferably at least at temperatures equal to, orgreater than, 150 degrees Centigrade, at or greater than 1 atmosphere.Thus, any material that forms the attachment structure that attaches toa sponge, including a pouch, thread, adhesive, or weld, retainsstructural and functional integrity, including for instance adhesiveintegrity at one or more of 121 degrees Centigrade, 130 degreesCentigrade, 136 degrees Centigrade, or 150 degrees Centigrade. Likewise,any material that forms the attachment structure that attaches to aninstrument or tool, including a housing, adhesive, epoxy, pottingmaterial or weld, retains structural and functional integrity, includingfor instance adhesive integrity at one or more of 121 degreesCentigrade, 130 degrees Centigrade, 136 degrees Centigrade, or 150degrees Centigrade.

The various materials preferably retain structural and functionalintegrity at least at ionizing radiation dosages of betweenapproximately 8 and 15 kilogray (kGy), or more preferably betweenapproximately 25 and 40 kGy, or even more preferably betweenapproximately 50 and 100 kGy.

The RFID transponder, other RF transponder and/or integrated circuitretains structural and functional integrity at least at ionizingradiation dosages of between approximately 8 and 15 kilogray (kGy), ormore preferably between approximately 25 and 40 kGy, or even morepreferably between approximately 50 and 100 kGy, for from approximately1 minute to 12 minutes.

The attachment structure retains structural and functional integrity atleast at least at ionizing radiation dosages of between approximately 8and 15 kGy, or more preferably between approximately 25 and 40 kGy, oreven more preferably between approximately 50 and 100 kGy, for fromapproximately 1 minute to 12 minutes. Thus, any material that forms theattachment structure that attaches to a sponge, including a pouch,thread, adhesive, or weld, retains structural and functional integrity,including for instance adhesive integrity at least at ionizing radiationdosages of between approximately 8 and 15 kGy, or more preferablybetween approximately 25 and 40 kGy, or even more preferably betweenapproximately 50 and 100 kGy, for from approximately 1 minute to 12minutes. Likewise, any material that forms the attachment structure thatattaches to an instrument or tool, including a housing, adhesive, epoxy,potting material or weld, retains structural and functional integrity,including for instance adhesive integrity at least at ionizing radiationdosages of between approximately 8 and 15 kGy, or more preferablybetween approximately 25 and 40 kGy, or even more preferably betweenapproximately 50 and 100 kGy, for from approximately 1 minute to 12minutes. Radiation sterilization of medical products is regulated underISO 11137 (2006) part 1, part 2 and part 3.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In the drawings, identical reference numbers identify similar elementsor acts. The sizes and relative positions of elements in the drawingsare not necessarily drawn to scale. For example, the shapes of variouselements and angles are not necessarily drawn to scale, and some ofthese elements may be arbitrarily enlarged and positioned to improvedrawing legibility. Further, the particular shapes of the elements asdrawn, are not necessarily intended to convey any information regardingthe actual shape of the particular elements, and may have been solelyselected for ease of recognition in the drawings.

FIG. 1A is a schematic diagram illustrating a clinical or surgicalenvironment where a medical provider uses an interrogation and detectionsystem to detect a wirelessly detectable medical procedure object in apatient, according to one illustrated embodiment.

FIG. 1B is an isometric view of a medical procedure object tagged with awirelessly detectable transponder to form a wirelessly detectablemedical procedure object, according to one illustrated embodiment, thetransponder which maintains structural and functional integrity understerilization procedures and conditions, for instance when exposed toionizing radiation at sterilization dosages for the medical procedureobject and/or elevated temperatures and/or pressures according tosterilization protocols for the medical procedure object.

FIG. 2A is a front view of a portion of a wirelessly detectable medicalprocedure object comprising a medical procedure object in the form of apiece of absorbent material, gauze or sponge, and a pouch that holds orcarries a presence or “dumb” transponder, according to one illustratedembodiment, the pouch and the wireless transponder(s) which eachmaintain structural and functional integrity when subjected tosterilization procedures and conditions.

FIG. 2B is a front view of a wirelessly detectable medical procedureobject comprising a medical procedure object and another pouch thatincludes a presence or “dumb” transponder, according to one illustratedembodiment, the pouch and the transponder each of which maintainstructural and functional integrity when subjected to sterilizationprocedures and conditions.

FIG. 3 is a front view of a portion of a wirelessly detectable medicalprocedure object comprising an RFID transponder and presence or dumbtransponder coupled to a medical procedure object via an attachmentstructure, according to one illustrated embodiment, the medicalprocedure object in the form of a piece of absorbent material, gauze orsponge, each of the medical procedure object, transponders, andattachment structure which maintain structural and functional integrityunder sterilization procedures and conditions.

FIG. 4 is a front view of an attachment structure that comprises apouch, the pouch which holds or carries a presence transponder freelymovable within an interior cavity of the pouch and an RFID transponder,according to one illustrated embodiment, each of the attachmentstructure and wireless transponders which maintain structural andfunctional integrity under sterilization procedures and conditions.

FIG. 5A is a top view of an attachment structure that comprises a pouch,the pouch which holds or carries a presence transponder and an RFIDtransponder, according to one illustrated embodiment, each of theattachment structure and wireless transponders which maintain structuraland functional integrity under sterilization procedures and conditions.

FIG. 5B is an exploded isometric view of the pouch of FIG. 5A.

FIG. 5C is first and second exploded side views of the pouch of FIGS. 5Aand 5B.

FIG. 6A is a top view of an attachment structure that comprises a pouch,the pouch which holds or carries a presence transponder and an RFIDtransponder, according to one illustrated embodiment, each of theattachment structure and wireless transponders which maintain structuraland functional integrity under sterilization procedures and conditions.

FIG. 6B is an exploded isometric view of the pouch of FIG. 6A.

FIG. 6C is first and second exploded side views of the pouch of FIGS. 6Aand 6B.

FIG. 7 is a cross-sectional diagram of an attachment structure in theform of a pouch that holds or carries a presence transponder, an RFIDtransponder and an optional a directional antenna formed on or withinthe pouch, according to one illustrated embodiment, all of whichmaintain structural and functional integrity under sterilizationprocedures and conditions.

FIG. 8 is a cross-sectional diagram of an attachment structure thatcarries a presence or dumb transponder, an RFID transponder 806, andoptionally a directional antenna, according to one illustratedembodiment, all of which maintain structural and functional integrityunder sterilization procedures and conditions.

FIG. 9 is a cross-sectional diagram of an attachment structure thatcarries a presence or dumb transponder, an RFID transponder, andoptionally a directional antenna, according to one illustratedembodiment, all of which maintain structural and functional integrityunder sterilization procedures and conditions.

FIG. 10 is a schematic diagram of a manufacturing system to manufacturewirelessly detectable medical objects using continuous web and RF orheat welding techniques, according to one illustrated embodiment, thewirelessly detectable medical objects which maintain structural andfunctional integrity under sterilization procedures and conditions.

FIG. 11 shows flexible layers usable to manufacture a plurality ofpouches, according to one illustrated embodiment, all of which maintainstructural and functional integrity under sterilization procedures andconditions.

FIG. 12 shows manufacture of a plurality of pouches using an RF or heatwelding technique, according to one illustrated embodiment, whichmaintains structural and functional integrity under sterilizationprocedures and conditions.

FIG. 13 is a front view of a plurality of pouches manufactured using anRF or heat welding technique, according to one illustrated embodiment,the pouches which maintain structural and functional integrity understerilization procedures and conditions.

FIG. 14A shows a piece of gauze with first and second radio-opaquematerial and a wireless transponder, being folded across a firstfold-line, according to at least one illustrated embodiment.

FIG. 14B shows the piece of gauze of FIG. 14A folded across the firstfold-line, one half of the piece of gauze overlying the other half ofthe piece of gauze, according to at least one illustrated embodiment.

FIG. 14C shows the piece of gauze of FIG. 14B being folded across asecond fold-line, according to at least one illustrated embodiment.

FIG. 14D shows the piece of gauze of FIG. 14C folded across the secondfold-line in a folded configuration, four portions of the piece of gauzeoverlying one another with the radio-opaque material on respective innerpieces or panels of the piece of gauze with respect to a pair of outerpieces or panels of the piece of gauze, according to at least oneillustrated embodiment.

FIG. 14E is top elevational view of the piece of gauze of FIG. 14D inthe folded configuration, better illustrating the four portions of thepiece of gauze overlying one another with the radio-opaque material onrespective inner pieces or panels of the piece of gauze with respect toa pair of outer pieces or panels of the piece of gauze.

FIG. 15A is a schematic diagram showing a surgical environmentillustrating use of an interrogation and detection system to detect oneor more objects tagged with a transponder in a patient, according to atleast one illustrated embodiment.

FIG. 15B is an isometric view of an apparatus to physically couple oneor more transponders to a surgical object, according to at least oneillustrated embodiment.

DETAILED DESCRIPTION

In the following description, certain specific details are set forth inorder to provide a thorough understanding of various disclosedembodiments. However, one skilled in the relevant art will recognizethat embodiments may be practiced without one or more of these specificdetails, or with other methods, components, materials, etc. In otherinstances, well-known structures associated with transmitters,receivers, or transceivers, and types of objects employed in medicalprocedures, for instance sponges, gauze or other absorbent objects, orinstruments such as clips, clamps, forceps, scalpels, endoscopes, havenot been shown or described in detail to avoid unnecessarily obscuringdescriptions of the embodiments.

Unless the context requires otherwise, throughout the specification andclaims which follow, the word “comprise” and variations thereof, such as“comprises” and “comprising,” are to be construed in an open, inclusivesense, as “including, but not limited to.”

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure or characteristicdescribed in connection with the embodiment is included in at least oneembodiment. Thus, the appearances of the phrases “in one embodiment” or“in an embodiment” in various places throughout this specification arenot necessarily all referring to the same embodiment. Furthermore, theparticular features, structures, or characteristics may be combined inany suitable manner in one or more embodiments.

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include plural referents unless the contentclearly dictates otherwise. It should also be noted that the term “or”is generally employed in its sense including “and/or” unless the contentclearly dictates otherwise.

The headings and Abstract of the Disclosure provided herein are forconvenience only and do not interpret the scope or meaning of theembodiments.

For ease of understanding, a clinical environment (e.g., surgicalenvironment) will be used as an example environment for detectingobjects but such should not be considered limiting. The structures andmethods described herein may be employed in other clinical environments,for example labor and delivery rooms, physician offices, emergencyrooms, etc.

FIG. 1A shows a clinical or surgical environment 100 in which medicalprocedures are performed, for example an operating room, clinician'soffice, labor and delivery room, examination room, patient room or otherenvironments in which medical procedures may be performed.

A medical provider 102 operates an identification and detection system104 to ascertain that wirelessly detectable medical procedure objects106 are not unintentionally left in a cavity or opening (e.g., wound,surgical incision, orifice) 105 in a body 107 of a patient 108. Forexample, the identification and detection system 104 may interrogate orexcite wireless (e.g., radio frequency or microwave frequency)transponders 120, 122 (FIG. 1B) attached to a medical procedure object,and detect a response therefrom. The wireless transponders may take theform of radio frequency identification (RFID) transponders 120 (FIG.1B), which store and/or return a unique identifier in response to aninterrogation signal. Additionally, or alternatively, the wirelesstransponders may take the form of LC resonant circuit transponders 122(FIG. 1B), which do not store or return unique identifiers and hence aredenominated as “dumb” transponders 122.

Referring again to FIG. 1A, the identification and detection system 104includes a controller 110, and one or more antennas 112 a, 112 b coupledto the controller 110 by one or more communication paths, for example acoaxial cable 114 a, 114 b. The antenna 112 a may take the form of ahand-held wand 116 a. In some implementations, the handheld antenna 112a is sized to fit at least partially in the cavity or opening 105.Additionally or alternatively, the antenna 112 b may take the form ofmat 116 b or be incorporated into a bed or table 116 c. In someimplementations, the antenna 112 b may include a plurality of coils,each extending across a width of the mat 116 b or table 116 c, andsequentially arranged along at least a portion of a length of the mat116 b or table 116 c to allow scanning of most or all of the patient108.

The controller 110 causes the antennas 112 a, 112 b to emit one or morewireless interrogation or excitation signals in one or more frequencybands, receives response signals to such interrogation or excitationsignals from one or more wirelessly detectable medical procedure objects106 via the antennas 112 a, 112 b. The controller 110 autonomouslyconfirms that no wirelessly detectable medical procedure objects 106 areunintentionally left or retained in the body 107 based at least in parton the received response signals.

In particular, the antennas 112 a, 112 b can emit a first interrogationsignal in a first frequency range and receive the first response signalfrom the RFID transponder 120. The console can decode the identifierencoded in the response signal(s), and/or update a list or databaseaccordingly (e.g., check in, check out, count in, count out). Theantennas 112 a, 112 b can further emit a second excitation orinterrogation signal in a second frequency, receive the second responsesignal from the presence or dumb transponder 122, and receive a responsesignal, receipt of which is indicative of a presence of a presence of awireless detectable medical procedure object 106 in the body 107.

Specific details of components of the antennas 112 a, 112 b are notdiscussed herein to not unnecessarily obscure the description of theembodiments. Components configured for emission of the interrogationsignals and for receiving the first and second response signals can beselected from any suitable scanning technology, including, but notlimited to, the detection device disclosed in U.S. Pat. No. 6,026,818,to Blair et al.; U.S. Pat. No. 7,696,877, to Barnes et al.; and U.S.Patent Publication No. 2013-0016021 by Blair, each of which areincorporated herein by reference.

Furthermore, in some implementations, the controller 110 of theinterrogation device or assembly includes an interface that displays thename of the wirelessly detectable medical procedure objects 106 as theidentification and detection system 104 scans the wirelessly detectablemedical procedure objects 106. For example, the interface may display anaccounting or inventory or list of sponges, gauzes, padding, hemostats,clips, clamps, forceps, scissors, scalpels, or other surgical orclinical tools or accessories, or any other wirelessly detectablemedical procedure objects 106, for an expedient accounting of thewirelessly detectable medical procedure objects 106 being used during aparticular clinical procedure.

When using RFID transponders 120, the identification and detectionsystem 104 may interrogate the RFID transponders 120 before or at astart of a medical procedure, populating a list or database ofwirelessly detectable medical procedure objects 106 by counting in orchecking in each wirelessly detectable medical procedure object 106based on unique identifiers returned from RFID transponders 120 attachedto respective ones of the wirelessly detectable medical procedureobjects 106. The identification and detection system 104 may interrogatethe RFID transponders 120 after or at an end of a medical procedure,comparing against the list or database of wirelessly detectable medicalprocedure objects 106 by counting out or checking out each object basedon unique identifiers returned from RFID transponders 120 attached torespective ones of the wirelessly detectable medical procedure objects106.

When using LC resonant or dumb transponders 122, the identification anddetection system 104 may interrogate or otherwise excite the dumbtransponders 122 during a medical procedure, for instance just prior toclosing of a wound or surgical opening. The identification and detectionsystem 104 may determine the presence or absence of wirelesslydetectable medical procedure objects 106 in, or on, a patient 108, forexample in or on a surgical site, procedure site, area, cavity, opening,or orifice 105.

The wirelessly detectable medical procedure object 106 may take avariety of forms of medical procedure objects, with one or moretransponders physically attached thereto. For example, the medicalprocedure objects 106 may take the form a durable or reusable medicalprocedure object, for instance an instrument or tool useful inperforming medical procedures, for instance surgical or labor anddelivery (L&D) procedures. For instance, the medical procedure object106 may take the form of scalpels, scissors, forceps, hemostats,dilators, needles, a drill bit, clips and/or clamps or other clinically,medically or surgically useful objects. Also for example, the medicalprocedure objects 106 may take the form of accessories and/or disposableobjects, for instance surgical sponges, gauze and/or padding. Thesurgical sponges, gauze and/or padding may be, as examples, 2 inches by2 inches, 4 inches by 4 inches, 12 inches by 12 inches, or other sizes.Such dimensions may refer to the surgical sponges, gauze and/or paddingas folded or otherwise packaged.

According to an aspect of the present disclosure, the wirelesslydetectable medical procedure object 106 comprises a medical procedureobject tagged, carrying, attached or otherwise coupled to a one or morewireless transponders 120, 122 via one or more attachment structures118.

In particular, referring now to FIG. 1B, one or more wirelesstransponders 120, 122 is physically coupled to or otherwise physicallyassociated with each medical procedure object by an attachment structure118 to create or form a wirelessly detectable medical procedure object106, for use within the clinical or surgical environment 100. The one ormore wireless transponders can receive and respond to wireless signals.For example, in some implementations, a radio frequency identification(RFID) transponder 120, when interrogated, wirelessly returns a firstresponse signal that contains unique identification information.Alternatively or additionally, a presence transponder 122, when excitedat a resonance frequency or interrogated, wirelessly returns a secondresponse signal that does not contain identification information.

Thus, in some implementations, the medical provider 102 can operate theidentification and detection system 104 to confirm that wirelesslydetectable medical procedure objects 106 where not unintentionally leftbehind in the patient 108. For example, the identification and detectionsystem 104 may autonomously determine the presence or absence ofwirelessly detectable medical procedure object 106 through wirelessinterrogation of the presence or dumb transponder 122. Also for example,the identification and detection system 104 may autonomously obtainidentification information through wireless interrogation of the RFIDtransponder 120, counting or checking in and counting or checking outeach wirelessly detectable medical procedure object 106 for a givenmedical procedure.

In some implementations, respective interrogation or excitation of andresponse by the presence transponder 122 and the RFID transponder 120can occur in two different frequency ranges. For example, the frequencyrange associated with excitation of and response by the presence or dumbtransponder 122 can include lower frequencies than the frequency rangeassociated with interrogation of and response by the RFID transponder120. Such lower frequencies may enable superior transmission of signalsthrough bodily tissues or other obstacles including membranes, skin,flesh, etc. Thus, in some implementations, excitation of, and responseby, the presence transponder 122 is possible at larger physicaldistances than interrogation of and response by the RFID transponder120.

The RFID transponder 120 includes an integrated circuit electricallycoupled to an antenna. The RFID transponder 120 may be relatively small,such as, for example, approximately 12 millimeters in diagonal.

In some implementations, the antenna can include an inductive windingsuch as a conductive wire wound about a core. The core can be fabricatedfrom a ferrite rod. The inductive winding is electrically coupled to anintegrated circuit. In other implementations, the antenna includes aconductive trace or other structures. The RFID transponder 120 may be anactive device that includes a local consumable power source such as abattery, or alternatively may be a passive device that relies on energyharvested or derived from the interrogation signal to power the RFIDtransponder 120.

The RFID transponder 120 may have physical characteristics thataccommodate or withstand the rigors of sterilization procedures orprotocols.

For example, the RFID transponder 120 takes the form of a radiation hardRFID transponder, that is an RFID transponder with a radiation hard orhardened RFID integrated circuit and/or front end. Radiation hard RFIDtransponders 120 retain structural and functional integrity to ionizingradiation at least at ionizing radiation dosages of betweenapproximately 8 and 15 kilogray (kGy), or more preferably betweenapproximately 25 and 40 kGy, or even more preferably betweenapproximately 50 and 100 kGy, for from approximately 1 minute to 12minutes.

The RFID transponder 120 may preferably take the form of a write once,read many times of memory circuit, which may advantageously enhance theradiation hardness of the RFID transponder 120. Additionally oralternatively, the RFID transponder's 120 integrated circuit may beformed on an insulating substrate, for instance using silicon oninsulator or silicon on sapphire substrates. The substrate may beselected to have a relatively wide band gap, for example employinggallium nitride of silicon carbide. Additionally or alternatively, theRFID transponder's 120 integrated circuit may employ bipolar integratedcircuits or bipolar junction transistors, in lieu of field effecttransistors (FETs). Additionally or alternatively, the RFIDtransponder's 120 integrated circuit may include SRAM in lieu of DRAM.Additionally or alternatively, the RFID transponder's 120 integratedcircuit may be encapsulated with a shielding, for instance using aborophophosilicate glass with depleted boron, to harden the integratedcircuit from X-ray and Gamma ray radiation. Additionally oralternatively, the RFID transponder's 120 integrated circuit may includefirmware or software mechanisms to correct for errors introduced byexposure to ionizing radiation. For instance, the integrated circuit mayimplement error correction, for example via parity checking, can employredundant logic elements, and/or radiation hardened latches.

Materials to fabricate the RFID transponder and associated integratedcircuit are selected accordingly. For example, material selected toserve as a substrate may be a polymer, so should be a polymer thatwithstands the aforementioned dosages of the ionizing radiation, as wellas any temperatures and/or pressures that the RFID transponder may besubjected to in undergoing sterilization. Many polymers are resistant toradiation doses of up to approximately 25 KGy, for example poly methylmethacrylate, polyurethane or thermosetting polyurethane, polyolefinsand other thermoplastics, polymer blends containing aromatic groups suchas polystyrene or containing nanoparticles or antioxidants.

Also for example, the RFID transponder 120 retains structural andfunctional integrity at temperatures and/or pressures specified bysterilization procedures or protocols. For instance, the RFIDtransponder 120 retains structural and functional integrity at least attemperatures equal to 121 degrees Centigrade, or more preferably atleast at temperatures equal to 130 degrees Centigrade, or even morepreferably at least at temperatures equal to 136 degrees Centigrade, ormost preferably at least at temperatures equal to, or greater than, 150degrees Centigrade, at or greater than 1 atmosphere. Materials tofabricate the RFID transponder and associated integrated circuit areselected accordingly. For example, material selected to serve as asubstrate may be a polymer, so should be a polymer that withstands theaforementioned temperatures and pressures, as well as dosages of theionizing radiation. For example, various thermosetting polymers may beemployed, or silicon or sapphire.

The RFID transponder 120 is operable to transmit (e.g., via activeradiation of the antenna) a first response signal that containsidentification information, in response to receiving an interrogationsignal in a first frequency range. The first response signal encodes theidentification information or identifier stored by the integratedcircuit. As such, the RFID transponder 122 may be denominated as a“smart” transponder.

The identification information included in the first response signal maybe a unique identifier (i.e., unique over a set of all otherwiseidentical RFID transponders 120). Alternatively, the identifier may notbe unique, for example, a set of RFID transponders 120 may each have thesame identifier. Even where the identifier is unique, some portion ofthe identification information or some other identification informationmay not be unique, for example, a portion representing a manufacturer, alot, or a type, may be shared between transponders 120 from the samemanufacturer, lot or of the same type. In some implementations, theidentification information can be associated with a type of thewirelessly detectable medical procedure object 106 or an attributethereof. For example, the identification information can be linked tothe type or attribute using a database, lookup table, or other datastructure that cross-references unique identifiers with the type orattribute.

Alternatively, in implementations where the integrated circuit of theRFID transponder 120 has read and write capability, the identificationinformation can include the desired attribute, pre-stored or writtenonto the integrated circuit, and directly convey the pre-storedattribute via the first response signal.

Furthermore, in some implementations, the RFID transponder 120 is aprintable and/or ultra-low-cost RFID transponder 120 that is notnecessarily intended to maintain functionality beyond a single use ofthe wirelessly detectable medical procedure object 106, and henceexposure to only one or two sterilization cycles. Such may be commonwith disposables, for instance sponges, gauze or pads, as opposed tomore durable instruments or tools Recognition of the limited servicelife of a medical procedure object may advantageously permit inclusionof a lower-cost RFID transponder 120 with lower resistance tosterilization than might otherwise be used for more durable instrumentsor tools.

The presence or dumb transponder 122 may be constructed in variousmanners. For example, the presence or dumb transponder 122 may include aferrite rod with a conductive coil wrapped about an exterior surfacethereof to form an inductor, and a capacitor coupled to the conductivecoil to form a series circuit. The conductive coil may, for example,take the form of a spiral wound conductive wire with an electricallyinsulative sheath or sleeve. For example, the inductive coil andcapacitor may together form an inductive/capacitance (L/C) tank circuit.Additional details about types of transponders may be found in U.S.Provisional Patent Application Ser. No. 60/811,376 filed Jun. 6, 2006and U.S. Provisional Patent Application Ser. No. 60/892,208, filed Feb.28, 2007, both of which are incorporated herein by reference.

The presence or dumb transponder 122 may have physical characteristicsthat accommodate or withstand the rigors of sterilization procedures orprotocols.

For example, the presence or dumb transponder 122 takes the form of aradiation hard LC resonant transponder, that is an LC resonanttransponder with a radiation hard or hardened circuitry (e.g.,capacitor). Radiation hard presence or dumb transponders 122 retainstructural and functional integrity to ionizing radiation at least ationizing radiation dosages of between approximately 8 and 15 kilogray(kGy), or more preferably between approximately 25 and 40 kGy, or evenmore preferably between approximately 50 and 100 kGy, for fromapproximately 1 minute to 12 minutes. The radiation hard presence ordumb transponders 122 integrated circuit may, for example, beencapsulated with a shielding, for instance using a borophophosilicateglass with depleted boron, to harden the integrated circuit from X-rayand Gamma ray radiation.

Also for example, the presence or dumb transponders 122 retainsstructural and functional integrity at temperatures and/or pressuresspecified by sterilization procedures or protocols. For instance, thepresence or dumb transponders 122 retains structural and functionalintegrity at least at temperatures equal to 121 degrees Centigrade, ormore preferably at least at temperatures equal to 130 degreesCentigrade, or even more preferably at least at temperatures equal to136 degrees Centigrade, or most preferably at least at temperaturesequal to, or greater than, 150 degrees Centigrade, at or greater than 1atmosphere. Ferrite and many metal, as well as silicon can withstandthese temperatures and pressures.

The presence transponder 122 is operable to transmit (e.g., viaradiation of the inductive coil) a second response signal, in responseto receiving an excitation signal in a second frequency range. Thesecond response signal does not include any unique identifyinginformation and, therefore, indicates only that the presence transponder122 is present. As such, the presence transponder 122 may be denominatedas a “dumb” transponder. However, in some implementations, presencetransponder 122 provides superior response strength through bodilytissue relative to the RFID transponder 120.

The presence transponder 122 may be relatively small, for exampleapproximately 5-10 millimeters long with a diameter of about 1-4millimeters. In at least some embodiments, an encapsulant advantageouslyprotects the transponder from the ambient environment, for instance fromforces, shock, pressure, heat, ionizing radiation, and/or fluids, suchas bodily fluids.

In some implementations, the presence transponder 122 includes adumbbell-shaped ferrite rod having broad end portions and a narrowintermediate portion. The broad end portions may provide capacitivefunctionality. In other implementations, the presence transponder 122may be shaped as a fusiform-shaped object, with truncated ends.

In further implementations, the wirelessly detectable medical procedureobject 106 includes at least one directional antenna. For example, insome implementations, an active antenna element of the RFID transponder120 forms at least a portion of the directional antenna. In someimplementations, the wirelessly detectable medical procedure object 106does not include the presence or dumb transponder 122. Particularexample structures and arrangements of the wirelessly detectable medicalprocedure object 106 are discussed further below with reference to theFigures that follow.

FIG. 1B depicts the wirelessly detectable medical procedure object 106as comprising an RFID transponder 120, dumb transponder 122 andattachment structure 118 that physically couples the RFID transponder120 and dumb transponder 122 to an external surface of a medicalprocedure object in the form of a piece of gauze 127. Notably, the pieceof gauze 127 may then be folded and/or stitched to form a pad or sponge.In particular, the piece of absorbent material or gauze 127 may befolded or otherwise manipulated such that the RFID transponder 120and/or dumb transponder 122 are no longer carried on an external surfaceof the resulting pad or sponge and/or externally visible. As an example,the piece of absorbent material or gauze 127 may be folded intoquadrants to provide, for example, a folded sponge, gauze, or paddingthat has four discernable layers. As a result of the folding, the RFIDtransponder 120 and/or dumb transponder 122 may be carried internallybetween layers of the piece of absorbent material or gauze 127 andvisible only upon unfolding of the piece of absorbent material or gauze127. Likewise, one or more pieces of radio-opaque material (e.g., radioopaque threads, barium threads) 129 a, 129 b, may be positioned suchthat when the piece of absorbent material or gauze 127 is folded, thepieces of radio-opaque material 129 a, 129 b preferably appear on innerlayers, folds or portions of the resulting pad or sponge, spacedinwardly and between a pair of outermost layers, folds or portions ofthe resulting pad or sponge.

The attachment structure 118 may include or consist of an adhesive layer131 that directly or indirectly physically couples the RFID transponder120 and/or dumb transponder 122 to the piece of absorbent material orgauze 127 or other medical procedure object (e.g., sponge, instrument,tool). The adhesive layer 131 may retain structural and adhesiveintegrity at least at temperatures equal to 121 degrees Centigrade, 130degrees Centigrade, 132 degrees Centigrade, 136 degrees Centigrade,and/or 150 degrees Centigrade, or higher.

For example, the adhesive layer 131 may not melt or otherwise liquefyand may maintain functional adhesion at temperatures less than or equalto 121 degrees Centigrade, 130 degrees Centigrade, 132 degreesCentigrade, 136 degrees Centigrade, and/or 150 degrees Centigrade orhigher.

As an example, the adhesive layer 131 may be a hot melt adhesive layerpositioned between the medical procedure object (e.g., gauze 127) andthe RFID transponder 120 and/or dumb transponder 122 or a pouch orsubstrate 133 which carries the RFID transponder 120 and/or dumbtransponder 122. In such implementations, the RFID transponder 120and/or dumb transponder 122 may be directly or indirectly physicallycoupled to the medical procedure (e.g., surgical, labor and delivery),for example piece of gauze 127 by causing the temperature of at least aportion the hot melt adhesive layer to exceed a melting pointtemperature associated with the hot melt adhesive layer, thereby causingsuch portion to at least in part melt. For example, such may beperformed using an RF welding machine, planar heat pressing machine,hot-air welding machine, or laminator. Alternatively, the wirelesslydetectable medical procedure object 106 may be baked (e.g., in achamber) or exposed to various other techniques for applying heat and/orpressure at desired locations. Generally, the melting point temperaturewill be at least greater than 121 degrees Centigrade, but may be othertemperatures.

Thus, for example, in contrast to an epoxy that is applied in liquidform and then cured, the adhesive layer 131 of the attachment structure118 may be a pre-formed solid layer that is positioned or laid betweenthe RFID transponder 120 and/or dumb transponder 122 and the medicalprocedure object (e.g., sponge 127). The adhesive layer 131 may then becaused to at least in part melt and then re-solidify, thereby engagingthe remainder of the RFID transponder 120 and/or dumb transponder 122with the medical procedure object (e.g., sponge 127) and resulting indirect or indirect physical coupling therebetween.

In some implementations, the hot melt adhesive layer 131 is a hightemperature hot melt adhesive layer (i.e., a hot melt adhesive layerthat has a relatively high melting point temperature) 131. For example,the hot melt adhesive layer 131 may have a melting point temperature ofgreater than 121 degrees Centigrade, greater than 130 degreesCentigrade, greater than 132 degrees Centigrade, or greater than 136degrees Centigrade. As another example, the hot melt adhesive layer 131may have a melting point temperature of about 150 degrees Centigrade orhigher.

More particularly, according to an aspect of the present disclosure, thehot melt adhesive layer 131 may have a melting point temperature greaterthan a sterilization temperature associated with one or moresterilization procedures. For example, the hot melt adhesive layer 131may have a melting point temperature greater than a steam temperature atwhich a volume of steam is maintained during one or more steam-basedsterilization procedures. For example, two common steam-basedsterilization techniques use a volume of steam respectively maintainedat 121 degrees Centigrade (250 degrees Fahrenheit) and 132 degreesCentigrade (270 degrees Fahrenheit). The hot melt adhesive layer 131 mayhave a melting point temperature greater than one or both of suchtemperatures.

Further, certain sterilization procedures may be performed with pressureconditions greater than 1 atmosphere. The hot melt adhesive layer 131may any of the melting point temperature characteristics describedherein at such pressure conditions.

In some implementations, the adhesive layer 131 and optional pouch orsubstrate 133 is biocompatible, permitting use of the wirelesslydetectable medical procedure object 106 in vivo. In someimplementations, the adhesive layer 131 is an adhesive web film. In someimplementations, the adhesive layer 131 is a thermal lamination film.The adhesive layer 131 may be a meltable plastic layer, such as, forexample, a thermoplastic layer.

In some implementations, the adhesive layer 131 may be a thermosettingplastic layer that has an initial cure temperature at which thethermosetting plastic layer cures. For example, the initial curetemperature may be less than 130 degrees Centigrade. Subsequent tocuring, the thermosetting plastic layer may retain structural andadhesive integrity at least at temperatures less than or equal to 121,130, 132, 136, and/or 150 degrees Centigrade or higher.

In some implementations, the adhesive layer 131 may be a heat-activatedadhesive layer. Alternatively or additionally, the adhesive layer 131may be a pressure-activated adhesive layer 131 or a pressure-sensitiveadhesive layer 131. Alternatively or additionally, the adhesive layer131 may be a water-activated adhesive layer 131.

Additionally or alternatively, the adhesive layer, and optional pouch orsubstrate 133, may be radiation hard or hardened. For example, theadhesive layer 131, and optional pouch or substrate 133, retainsstructural and functional (e.g., adhesive) integrity to ionizingradiation at least at ionizing radiation dosages of betweenapproximately 8 and 15 kilogray (kGy), or more preferably betweenapproximately 25 and 40 kGy, or even more preferably betweenapproximately 50 and 100 kGy, for from approximately 1 minute to 12minutes.

The adhesive layer 131 may include at least one of thermoplasticpolyurethane, silicone, polyamide, polyethersulfone, polyethylene,polypropylene, and ethylene vinyl acetate, with or without aromaticgroups, nanoparticles or antioxidants.

As one example method of operation, a user, such as the medical provider102, can scan the patient 108 to detect presence or absence ofwirelessly detectable medical procedure objects 106 within the patient108 through wireless interrogation of one or more presence or dumbtransponders 122. For example, such interrogation of the presence ordumb transponders 122 can occur at a first physical distance. Upondetecting the presence of a wirelessly detectable medical procedureobject 106 within the patient 108, the medical provider 102 canimmediately scan the region of detection to wirelessly interrogate oneor more RFID transponders 120 and thereby identify the one or moreobjects 106 that remain. For example, such interrogation of the RFIDtransponders 120 can occur at a second physical distance that is lessthan the first physical distance. Having obtained the identity of thewirelessly detectable medical procedure object 106, the medical provider102 can make informed decisions with respect to handing of thewirelessly detectable medical procedure object 106. For example, themedical provider 102 can remove wirelessly detectable medical procedureobject 106 prior to closing a wound or opening in the body 107 of apatent 108.

As another example, upon removing the wirelessly detectable medicalprocedure object or objects 106 from the body 107 of the patient 108,and with all the wirelessly detectable medical procedure objects 106laid out in an area after a medical procedure (e.g., surgery, labor anddelivery) and before closing the surgical site, wound, incision, orificeor area 105, the medical provider 102 can scan the present objects 106to ensure that all the objects 106 that were present before surgery, arenow present and outside of the body 107 of the patient 108 after or justprior to completion of the medical procedure. For example, the medicalprovider 102 can interrogate the RFID transponder 120 of each wirelesslydetectable medical procedure object 106 to identify all which arepresent. The wirelessly detectable medical procedure objects 106 whichare identified as present can be compared to a list or record ofwirelessly detectable medical procedure objects 106 identified andlogged or recorded prior to use within the surgical or clinicalenvironment to detect any discrepancies (i.e., missing objects).

As yet another example method of operation, one or more RFIDtransponders 120 for one or more wirelessly detectable medical procedureobjects 106 may be interrogated at a conclusion of or during amanufacturing process, for example, to ensure that an appropriate numberof objects 106 are included in a shipping tote or other package. Uponentry into and use of the wirelessly detectable medical procedureobjects 106 within the clinical or surgical environment, the RFIDtransponders 120 may or may not degrade. However, the medical provider102 may still interrogate one or more presence transponders 122 toadvantageously detect presence or absence of wirelessly detectablemedical procedure objects 106 within the patient 108.

Accordingly, the wirelessly detectable medical procedure objects 106 ofthe present disclosure provide the capability to efficiently detect apresence or absence of medical procedure related objects in or on thebody of the patient 108, and the capability to conduct an inventoryafter or just prior to completion of the medical or clinical procedure(e.g., surgery, labor and delivery) to ensure all wirelessly detectablemedical procedure objects 106 present at the start of a clinicalprocedure (e.g., surgery, labor and delivery) are present and accountedfor at the end of the medical or clinical procedure, without the use ofmultiple separately affixed optically-readable symbols (e.g., barcodesymbols) and without the need to conduct a manual count by highlytrained and highly paid personnel.

Further, although a human patient 108 is illustrated, the describedinterrogation and detection system 104 may similarly be used on animalsor inanimate subjects.

FIG. 2A shows a portion of a wirelessly detectable medical procedureobject 200 in the form of a piece of absorbent material, gauze or sponge227 and a pouch 202 that includes at least one wireless transponder, forinstance a presence or dumb transponder 206, according to oneillustrated embodiment. In particular, in some implementations, theattachment structure 118 comprises a pouch 202 that holds or otherwiseretains a presence or dumb transponder 206 within an interior cavity ofthe pouch 202. The pouch 202 is physically coupleable to a medicalprocedure object, for example a piece of absorbent material, gauze orsponge 127, to form the wirelessly detectable medical procedure object200.

In some implementations, the presence or dumb transponder 206 is freelymovable within the interior cavity of the pouch 202. Such mayadvantageously allow folding, stretching, compression, twisting, orother physical manipulation of the piece of absorbent material, gauze,sponge 127 or other medical procedure object without causing damage tothe presence or dumb transponder 206. For example, the presence or dumbtransponder 206 freely moves within the pouch 202 to an advantageousposition experiencing reduced forces. Likewise, the free-floatingpresence or dumb transponder 206 does not inhibit folding, stretching,compression, twisting, or other physical manipulation of the piece ofabsorbent material, gauze or sponge 127 or other object, which may benecessary for successfully performing the medical (e.g., surgical, laborand delivery) procedure.

The pouch 202 includes at least a first flexible layer 208 that formsthe interior cavity 209 of the pouch 202. For example, the firstflexible layer 208 can be physically coupled to a surface of an medicalprocedure object, e.g., a piece of absorbent material, gauze or sponge127 to form the interior cavity therebetween. As another example, asshown in FIG. 2A, the pouch 202 includes a second flexible layer 210opposite the first flexible layer 208 and physically coupled to thefirst flexible layer 208 to form the interior cavity 209 therebetween.

In the illustrated embodiment, the pouch 202 further includes anadhesive layer 212 positioned opposite the second flexible layer 210from the first flexible layer 208. The adhesive layer 212 may bephysically coupled to one or both of the first flexible layer 208 andthe second flexible layer 210. Furthermore, in some implementations, theadhesive layer 212 physically couples the pouch 202 to a piece ofabsorbent material, gauze or sponge 127 or other object.

The pouch 202, including the adhesive layer 212, may retain structuraland adhesive integrity at least at ionizing radiation dosages of betweenapproximately 8 and 15 kilogray (kGy), or more preferably betweenapproximately 25 and 40 kGy, or even more preferably betweenapproximately 50 and 100 kGy.

Additionally or alternatively, the pouch, including the adhesive layer212, may retain structural and adhesive integrity at least attemperatures equal to 121, 130, 132, 136, and/or 150 degrees Centigradeor higher. For example, the adhesive layer 212 may not melt or otherwiseliquefy and may retain adhesion to the first flexible layer 208, secondflexible layer 210 and/or the piece of the absorbent material, gauze orsponge 127 at temperatures less than or equal to 121, 130, 132, 136,and/or 150 degrees Centigrade or higher.

In some implementations, the adhesive layer 212 is physically coupled toat least a portion of a first surface of the second flexible layer 210and the first flexible layer 208 is physically coupled to at least aportion of a second surface of the second flexible layer 210 that isopposite the first surface. In particular, in some implementations, theadhesive layer 212 is physically coupled to at least the first surfaceof the second flexible layer 210 about a perimeter of the interiorcavity and the first flexible layer 208 is physically coupled to atleast the second surface of the second flexible layer 210 about theperimeter of the interior cavity 209. In such implementations, theinterior cavity 209 may be formed between the first flexible layer 208and the second flexible layer 210, as illustrated, or may be formedbetween the second flexible layer 210 and the adhesive layer 212.

In other implementations, the adhesive layer 212 is continuouslyphysically coupled to at least the first surface of the second flexiblelayer 210 and the first flexible layer 208 is physically coupled to atleast the second surface of the second flexible layer 210 about theperimeter of the interior cavity. In such implementations, the interiorcavity 209 may be formed between the first flexible layer 208 and thesecond flexible layer 210, as illustrated.

In yet other implementations, the pouch 202 includes the adhesive layer212, but does not include the second flexible layer 210. In suchimplementations, the first flexible layer 208 is physically coupled tothe adhesive layer 212. For example, the first flexible layer 208 may bephysically coupled to the adhesive layer 212 at least about theperimeter to form the interior cavity 209 therebetween.

In some implementations, a heat or radio frequency (RF) weld 204physically couples the first flexible layer 208 to one or both of thesecond flexible layer 210 and the adhesive layer 212. For example, theheat or RF weld 204 extends around a perimeter of the interior cavity209 and closes the presence transponder 206 within the pouch 202. Awidth of the heat or RF weld 204 can be varied to balance variousobjectives such as a strength of weld 204 and a size of the pouch 202.Alternatively or additionally to the heat or RF weld 204, adhesives,stitches, clamps, fasteners, or other securement or fastening structurescan physically couple the first flexible layer 208 to the medicalprocedure object (e.g., piece of absorbent material, gauze or sponge127) or the second flexible layer 210.

The first and/or second flexible layers 208 and 210 may be fabriclaminates or other materials. For example, the first and/or secondflexible layers 208 and 210 may be one or more of thermoplasticpolyurethane (TPU) and nylon fabric; polyvinyl chloride (PVC)impregnated fabric; layer(s) of PVC, TPU, PET, PETG, LDPE, EVA, opencelled polyurethanes, or nylon; other fabrics (e.g., cotton, polyester,leather, vinyl, polyethylene, and blended fabrics); other plastics; orcombinations thereof. The flexible layers 208 and 210 are typicallyrelatively thin and may be absorbent or non-absorbent. In someimplementations, the flexible layers are of material suitable to prevententry of fluids into the interior cavity of the pouch 202 (e.g., due toa water-proof or water-resistant coating). Thus, the first and/or secondflexible layers 208 and 210 may be soft, pliable, and resistant toripping or tearing.

In one particular example, the first flexible layer 208 includes a firstlayer of TPU and a first layer of nylon fabric. The second flexiblelayer 210 includes a second layer of TPU and a second layer of nylonfabric. For example, the first and second layers of TPU may respectivelybe located interior relative to the first and second layers of nylonfabric. In other words, the first and second layers of TPU may contacteach other and may form an interior surface of the interior cavity ofthe pouch 202 while the first and second layers of nylon fabric arerespectively carried by respective exterior surfaces of the first andsecond layers of TPU that are opposite to the interior cavity. Such mayadvantageously allow the first and second layers of TPU to morecompletely melt together or otherwise physically couple to each otherwhen the RF weld 204 is generated. However, in other implementations,the first and second layers of nylon fabric may be located interiorrelative to the first and second layers of TPU or may be embedded withinthe first and second layers of TPU.

In some implementations, the adhesive layer 212 is a hot melt adhesivelayer 212. In such implementations, the pouch 202 may be constructed atleast in part by causing the temperature of at least a portion the hotmelt adhesive layer 212 to exceed a melting point temperature associatedwith the hot melt adhesive layer 212, thereby causing such portion to atleast in part melt. For example, such may be performed using an RFwelding machine, planar heat pressing machine, hot-air welding machine,or laminator. Alternatively, the pouch 202 may be baked (e.g., in achamber) or exposed to various other techniques for applying heat and/orpressure at desired locations. Generally, the melting point temperaturewill be at least greater than 130 degrees Centigrade.

Thus, for example, in contrast to an epoxy that is applied in liquidform and then cured, the adhesive layer 212 may be a pre-formed solidlayer that is positioned or laid adjacent to the first and/or the secondflexible layers 208 and 210 and then caused to at least in part melt andthen re-solidify, thereby engaging the first and/or the second flexiblelayers 208 and 210 and resulting in physical coupling therewith. Forexample, in some implementations, the second layer 210 is a porousfabric and the adhesive layer 212 melts through the pores of the fabricto engage the first flexible layer 208. Such may result in physicalcoupling of the first flexible layer 208 to the second flexible layer210 by way of the adhesive layer 212. Further, in some implementations,the adhesive layer 212 may be caused to at least in part melt, engage apiece of a medical procedures object (e.g., piece of absorbent material,gauze or sponge 127) or other medical procedure object, and thenre-solidify, resulting in physical coupling of the pouch 202 to themedical procedure object such as piece of absorbent material, gauze orsponge 127.

In some implementations, the hot melt adhesive layer 212 is a hightemperature hot melt adhesive layer 212 (i.e., a hot melt adhesive layerthat has a relatively high melting point temperature). For example, thehot melt adhesive layer 212 may have a melting point temperature ofgreater than 121, 130, 132, or 136 degrees Centigrade. As anotherexample, the hot melt adhesive layer 212 may have a melting pointtemperature of about 150 degrees Centigrade or higher. Additionally oralternatively, the hot melt adhesive layer 212 may be a radiation hotmelt adhesive that retains structural and functional (e.g.,adhesiveness) integrity to ionizing radiation at least at ionizingradiation dosages of between approximately 8 and 15 kilogray (kGy), ormore preferably between approximately 25 and 40 kGy, or even morepreferably between approximately 50 and 100 kGy, for from approximately1 minute to 12 minutes, or even longer.

More particularly, according to an aspect of the present disclosure, thehot melt adhesive layer 212 may have a melting point temperature greaterthan a sterilization temperature associated with one or moresterilization procedures. For example, the hot melt adhesive layer mayhave a melting point temperature greater than a steam temperature atwhich a volume of steam is maintained during one or more steam-basedsterilization procedures. For example, two common steam-basedsterilization techniques use a volume of steam respectively maintainedat 121 degrees Centigrade (250 degrees Fahrenheit) and 132 degreesCentigrade (270 degrees Fahrenheit). The hot melt adhesive layer 212 mayhave a melting point temperature greater than one or both of suchtemperatures.

Further, certain sterilization procedures may be performed with pressureconditions greater than 1 atmosphere. The hot melt adhesive layer 212may any of the melting point temperature characteristics describedherein at such pressure conditions.

Also for example, a common sterilization technique uses ionizingradiation (e.g., X-ray, Gamma ray). The hot melt adhesive layer 212 mayretain structural integrity and its adhesive properties at suitabledosages, for instance approximately 25 kGy.

In some implementations, the adhesive layer 212 is biocompatible,permitting use of the wirelessly detectable object in vivo. In someimplementations, the adhesive layer 212 is an adhesive web film. In someimplementations, the adhesive layer 212 is a thermal lamination film.The adhesive layer 212 may be a meltable plastic layer, such as, forexample, a thermoplastic layer.

In some implementations, the adhesive layer 212 may be a thermosettingplastic layer that has an initial cure temperature at which thethermosetting plastic layer cures. For example, the initial curetemperature may be less than 130 degrees Centigrade. Subsequent tocuring, the thermosetting plastic layer may retain structural andadhesive integrity at least at temperatures less than or equal to 121,130, 132, 136, and/or 150 degrees Centigrade or higher. Subsequent tocuring, the thermosetting plastic layer may retain structural andadhesive integrity at least at ionizing radiation dosages of betweenapproximately 8 and 15 kilogray (kGy), or more preferably betweenapproximately 25 and 40 kGy, or even more preferably betweenapproximately 50 and 100 kGy, for from approximately 1 minute to 12minutes, or even longer.

In some implementations, the adhesive layer 212 may be a heat-activatedadhesive layer. Alternatively or additionally, the adhesive layer 212may be a pressure-activated adhesive layer or a pressure-sensitiveadhesive layer. Alternatively or additionally, the adhesive layer 212may be a water-activated adhesive layer.

The adhesive layer 212 may include at least one of thermoplasticpolyurethane, silicone, polyamide, polyethersulfone, polyethylene,polypropylene, and ethylene vinyl acetate. These polymers may, forexample, comprise a polymer blend, for instance containing aromaticgroups such as polystyrene or containing nanoparticles or antioxidants.

In one particular example pouch 202, the first flexible layer 208 is anylon layer; the second flexible layer 210 is a TPU layer; and theadhesive layer 212 is a hot melt adhesive layer. In someimplementations, the pouch 202 does not include the adhesive layer 212.

FIG. 2B shows a portion of a wirelessly detectable medical procedureobject 250 in the form of a piece of absorbent material, gauze or sponge127 and a pouch 252 that includes at least one wireless transponder, forinstance a presence or dumb transponder 256, according to oneillustrated embodiment. The pouch 252 is physically coupleable to amedical procedure object, for example a piece of absorbent material,gauze or sponge 127, to form the wirelessly detectable medical procedureobject 250.

In particular, pouch 252 includes a first flexible layer 258 physicallycoupled to a second flexible layer 260 by an RF weld 254. The presenceor dumb transponder 256 is received and freely movable within aninterior cavity 209 formed between the first and second flexible layers258 and 260. In particular, the RF weld 254 extends around a perimeterof the interior cavity 209 and closes the presence or dumb transponder256 within the interior cavity 209 of the pouch 252. The pouch 252 isphysically coupleable to a medical procedure object, for example a pieceof absorbent material, gauze or sponge 127. For example, the pouch 252includes an adhesive layer 262 positioned opposite the second flexiblelayer 260 from the first flexible layer 258. The adhesive layer 262 maybe a hot melt adhesive layer that is meltable to physically couple thepouch 252 to a piece of absorbent material, but that has a melting pointtemperature greater than one or more sterilization temperatures at whichcommon sterilization techniques are performed, thereby permitting thepouch 252 to remain physically coupled to the piece of absorbentmaterial through one or multiple sterilization cycles. The adhesivelayer 262 may also advantageously retain structural and adhesiveintegrity at least at ionizing radiation dosages of betweenapproximately 8 and 15 kilogray (kGy), or more preferably betweenapproximately 25 and 40 kGy, or even more preferably betweenapproximately 50 and 100 kGy, for from approximately 1 minute to 12minutes, or even longer.

FIG. 3 shows a wirelessly detectable medical object 300, which comprisesa piece of absorbent material, gauze or sponge 302 with an RFIDtransponder 306 and a presence or dumb transponder 312 physicallycoupled thereto via at least one attachment structure, for example apouch 304, according to one illustrated embodiment.

More precisely, a pouch 304 is physically coupled to the piece ofabsorbent material 302. The pouch 304 includes a first flexible layerphysically coupled to a second flexible layer to form an interior cavitytherebetween. The flexible layers may the same as or similar to layers208 and 210 discussed with reference to FIG. 2A, so are not specificallycalled out in FIG. 3. The pouch 304 may include an adhesive layer thatphysically couples the pouch 304 to the piece of absorbent material 302.The adhesive layer may be the same as or similar to layer 212 discussedwith reference to FIG. 2A. In some implementations, the pouch 304 doesnot include the adhesive layer.

A presence transponder 312 is retained and freely movable within theinterior cavity of the pouch 304. An RF weld 310 physically couples thefirst flexible layer to the second flexible layer. In someimplementations, the RF weld 310 further physically couples the pouch304 to the piece of absorbent material, gauze or sponge 302. In otherimplementations, an additional RF weld or other attachment structure(e.g. adhesive layer) physically couples the pouch 304 to the piece ofabsorbent material, gauze or sponge 302.

As shown in FIG. 3, the RFID transponder 306 is physically coupled tothe piece of absorbent material, gauze or sponge 302 separately from thepouch 304. Adhesives, stitching, clamping, fasteners, heat sealing, RFwelding, or other attachment structure physically couple the RFIDtransponder 306 the piece of absorbent material, gauze or sponge 302. Insome implementations, a radiopaque thread or object 308 is woven into orotherwise physically coupled to the piece of absorbent material, gauzeor sponge 302, as well.

Furthermore, although FIG. 3 depicts pouch 304 and RFID transponder 306as physically coupled to and visible upon an external surface of thepiece of absorbent material, gauze or sponge 302, in someimplementations, the piece of absorbent material, gauze or sponge 302 isfolded or otherwise manipulated such that the pouch 304 and RFIDtransponder 306 are internally carried between layers or folds orportions of the piece of absorbent material, gauze or sponge 302.

FIG. 4 shows an attachment structure 400 that comprises a pouch 402. Thepouch holds a presence or dumb transponder 408, freely movable within aninterior cavity 409 of the pouch 402 and an RFID transponder 410 with anantenna trace 412, according to one illustrated embodiment.

The pouch 402 includes a first flexible layer 404 physically coupled toa second flexible layer 405 to form an interior cavity 409 therebetween.The flexible layers 404 and 405 may the same as or similar to layers 208and 210 discussed with reference to FIG. 2A. The pouch 402 includes anadhesive layer 407 physically coupled to at least the second flexiblelayer 405. The adhesive layer 407 may be the same as or similar toadhesive layer 212 discussed with reference to FIG. 2A.

The presence transponder 408 is retained and freely movable within theinterior cavity 409 of the pouch 402. In particular, an RF weld 406physically couples the first flexible layer 404 to the second flexiblelayer 405 and closes or seals the presence or dumb transponder 408within the interior cavity 409.

The RFID transponder 410 includes an antenna trace 412 electricallycoupled to a chip 414. An integrated circuit that stores identificationinformation can form all or a portion of the chip 414.

All or a portion of the RFID transponder 410 can be embedded in and/oradhered to the first flexible layer 404. For example, in someimplementations, the chip 414 is adhered to the first flexible layer 404(e.g., adhered to a surface of the first layer 404 that faces theinterior cavity 409) while the antenna trace 412 is embedded within thefirst flexible layer 404. In other implementations, the antenna trace412 is printed or traced onto the first flexible layer 404 (e.g., ontoan interior surface that faces the interior cavity). In yet otherimplementations, all or a portion of the RFID transponder 410 isembedded in and/or adhered to the second flexible layer 405.

In some implementations, at least a portion of the first flexible layer404 and/or the second flexible layer 405 is a material that is absorbentbut remains electrically insulative, thereby contributing to anabsorbency of an attached piece of absorbent material withoutinterfering with an ability of the antenna trace 412 to transmit asignal.

As the presence transponder 408 is freely movable within the interiorcavity 409 of the pouch 402 and the RFID transponder 410 is embedded inand/or adhered to the first flexible layer 404, the presence transponder408 is independently movable with respect to the RFID transponder 410.Furthermore, as shown in FIG. 4, in some implementations, care is takento prevent the RF weld 406 from welding over and potentially damagingthe antenna trace 412. In addition, in some implementations, the pouch402 does not include the adhesive layer 407.

FIGS. 5A, 5B and 5C show a pouch 502 that holds a presence or dumbtransponder 508 b, freely movable within an interior cavity 509 formedbetween a first flexible layer 504 b and a substrate 506 b of the pouch502, according to one illustrated embodiment. An RFID transponder 512 bis adhered to the substrate 506 b.

An encapsulant 510 encapsulates the presence or dumb transponder 508 b.The encapsulant 510 may provide a shielding for the presence transponder508 b or for a capacitor thereof to harden the presence transponder 508b or capacitor with respect to X-ray and Gamma ray radiation. Theencapsulant 510 may, for instance, comprise a borophophosilicate glasswith depleted boron.

The substrate 506 b can be a second flexible layer, a surgical procedureobject, for instance a piece of absorbent material, gauze or sponge, orother substrates. In particular, the first flexible layer 504 b and thesubstrate 506 b may the same as or similar to layers 208 and 210discussed with reference to FIG. 2A. In some implementations, an RF weldphysically couples the first flexible layer 504 b to the substrate 506b. In the illustrated embodiment, the pouch 502 further includes anadhesive layer 507 b. The adhesive layer 507 b may be the same as orsimilar to layer 212 discussed with reference to FIG. 2A. However, insome implementations, the pouch 502 does not include the adhesive layer507 b.

FIG. 5C better illustrates the interior cavity 509 formed between thefirst flexible layer 504 c and the substrate 506 c of the pouch 502,according to one illustrated embodiment. As illustrated, the RFIDtransponder 512 c may be adhered to the substrate 506 c of the pouch502. For example, in some implementations, some or all of the RFIDtransponder 512 c (e.g., a chip portion) is adhered to the substrate 506c using adhesives or other securing means. In some implementations, someor all of the RFID transponder 512 c (e.g., an antenna portion) isprinted onto or traced upon the substrate 506 c. The illustrated pouch502 optionally includes an adhesive layer 507 c. The adhesive layer 507c may take the form of previously described adhesives. For example, theadhesive layer 507 c may retain its structural and functional integritywhen exposed to elevated temperatures and/or pressures and/or ionizingradiation dosages commonly employed during sterilization of objects tobe used in medical applications, such as clinical or surgicalprocedures, as previously specified herein.

FIGS. 6A, 6B and 6C show a pouch 602 that holds a presence or dumbtransponder 608 b and an RFID transponder 612 b freely movable within aninterior cavity 609 formed between a first flexible layer 604 b and asubstrate 606 b of the pouch 602, according to one illustratedembodiment. An encapsulant 610 a encapsulates the presence transponder608 b. An encapsulant 610 b encapsulates the RFID transponder 612 b. Theencapsulants 610 a, 610 b may provide a shielding for the presencetransponder 508 b and RFID transponder 612 b, respectively or for acapacitor the presence transponder 508 b or integrated circuit 613 ofthe RFID transponder 612 b, to harden the presence transponder 508 b orcapacitor and the RFID transponder 612 b or integrated circuit 613 withrespect to X-ray and Gamma ray radiation. The encapsulant 610 a, 610 bmay, for instance, comprise a borophophosilicate glass with depletedboron.

The substrate 606 b can be a second flexible layer, a surgical procedureobject, for instance a piece of absorbent material, gauze or sponge, orother substrates. In particular, the first flexible layer 604 b and thesubstrate 606 b may the same as or similar to layers 208 and 210discussed with reference to FIG. 2A. In some implementations, an RF weldphysically couples the first flexible layer 604 b to the substrate 606b. In the illustrated embodiment, the pouch 602 further includes anadhesive layer 607 b. The adhesive layer 607 b may be the same as orsimilar to layer 212 discussed with reference to FIG. 2A. However, insome implementations, the pouch 602 does not include the adhesive layer607 b.

FIG. 6C better illustrates the interior cavity 609 formed between thefirst flexible layer 604 c and the substrate 606 c of the pouch,according to one illustrated embodiment. The illustrated pouch 602includes the adhesive layer 607 c. As discussed above, the adhesivelayer 607 b may retain structural and functional (e.g., adhesiveness)integrity when subjected to conditions associated with sterilization,for instance elevated temperature, pressure and/or ionizing radiation,as specified above.

FIG. 7 shows an attachment structure 700 in the form of a pouch 701 thatcarries or holds at least one wireless transponder (e.g., presence ordumb transponder 708, RFID transponder 710) and optionally a directionalantenna formed on or contained within the pouch, according to oneillustrated embodiment.

In particular, the pouch 701 includes a first flexible layer 702physically coupled to a substrate 704 to form an interior cavity 706therebetween. A presence or dumb transponder 708 is received and freelymovable enclosed or retained within the interior cavity 706. Thesubstrate 704 can be a second flexible layer, a surgical object such asa piece of absorbent material, or other substrates. In particular, thefirst flexible layer 702 and the substrate 704 may the same as orsimilar to layers 208 and 210 discussed with reference to FIG. 2A.

In the illustrated embodiment, the attachment structure 700 furtherincludes an adhesive layer 703. The adhesive layer 703 may be the sameas or similar to layer 212 discussed with reference to FIG. 2A. However,in some implementations, the wirelessly detectable object 700 does notinclude the adhesive layer 703.

The attachment structure 700 holds an RFID transponder 710 that includesat least one active antenna element 712 and an integrated circuit 714.For example, the integrated circuit 714 can actively drive or energizethe active antenna element 712 of the RFID transponder 710 to transmit asignal. The RFID transponder 710 may be received and enclosed orretained within the interior cavity 706 of the pouch 701. The RFIDtransponder 710 may be freely movable within the interior cavity 706 ofthe pouch 701. Alternatively, the RFID transponder 710 may be secured orfixed within the interior cavity 706 of the pouch 701, for instancesecured to the substrate 704 or first flexible layer 702, for instancevia an adhesive. Alternatively, the RFID transponder 710 may form all ora portion of the pouch 701, for example forming a layer of the pouch701, or being part of a lamination of layers that form a portion (e.g.,substrate 704) the pouch 701.

The attachment structure 700 may further carry one or more passiveantenna elements 716 (only one shown) that, together with the activeantenna element 712, operates as a directional antenna. For example, thepassive antenna element 716 and the active antenna element 712 maytogether operate as a Yagi antenna.

As shown in FIG. 7, the passive antenna element 716 can be a separatestructure from the active antenna element 712 of the RFID transponder710. However, in other implementations, the passive antenna element 716and the active antenna element 712 may be included within a singleintegral structure. In some implementations, two or more passive antennaelements 716 act as a reflector element and a director element,respectively.

As shown in FIG. 7, the passive antenna element 716 may be adhered to orprinted, deposited or otherwise formed upon an interior surface of thefirst flexible layer 702 that faces the interior cavity 706. However, inother implementations, the passive antenna element 716 may be at leastpartially embedded in the first flexible layer 702 or adhered to orprinted, deposited or otherwise formed upon an exterior surface of thefirst flexible layer 702. The active antenna element 712 is adhered toor printed, deposited or otherwise formed upon an interior surface ofthe substrate 704 that faces the interior cavity 706. However, in otherimplementations, the active antenna element 712 may be at leastpartially embedded within the substrate 704 or adhered to or traced uponan exterior surface of the substrate 704.

In yet further implementations, the respective positions of the activeantenna element 712 and the passive antenna element 716 may be oppositeto those depicted in FIG. 7. That is, the passive antenna element 716may be adhered to or embedded within the substrate 704 while the activeantenna element 712 is adhered to or embedded within the first flexiblelayer 702.

All of the materials that form the attachment structure 700, as well asthe presence or dumb transponder 708 and the RFID transponder 710 mayretain their structural and functional integrity when exposed toelevated temperatures and/or pressures and/or ionizing radiation dosagescommonly employed during sterilization of objects to be used in medicalapplications, such as clinical or surgical procedures, as previouslyspecified herein. One or more components or structures may be protectedor shielded, for instance by an encapsulant that retains its structuraland functional integrity when exposed to elevated temperatures and/orpressures and/or ionizing radiation dosages commonly employed duringsterilization of objects to be used in medical applications, such asclinical or surgical procedures, as previously specified herein.

FIG. 8 shows an attachment structure 800 that carries at least onewireless transponder (e.g., presence or dumb transponder 812, RFIDtransponder 806) and optionally a directional antenna carried at leastin part by a first substrate 802, according to one illustratedembodiment.

The attachment structure 800 is physically coupled to a medicalprocedure object, for instance a piece of absorbent material, gauze orsponge 804. The attachment structure 800 may, for example, include anadhesive layer 815, which may be positioned between and respectivelyphysically coupled to the remainder of the attachment structure 800 andthe piece of absorbent material, gauze or sponge 804. However, in someimplementations, the attachment structure 800 does not include theadhesive layer 815.

The first substrate 802 may be a first flexible layer. For example, thefirst substrate 802 may be the same as or similar to layers 208 and 210discussed with reference to FIG. 2A. The adhesive layer 815 may be thesame as or similar to layer 212 discussed with reference to FIG. 2A.

The RFID transponder 806 includes an active antenna element 808 and anintegrated circuit 810. For example, the integrated circuit 810 mayselectively actively energize or otherwise cause the active antennaelement 808 to radiate to transmit a signal. The attachment structure800 may optionally carry or hold one or more passive antenna elements814 (only one shown) that, together with the active antenna element 808,operates as a directional antenna. For example, the passive antennaelement 814 and the active antenna element 808 may together operate as aYagi antenna.

As shown in FIG. 8, the passive antenna element 814 is positionedbetween the first substrate 802 and the piece of absorbent material,gauze or sponge 804. For example, the passive antenna element 814 can beadhered to, printed, deposited or otherwise formed onto, or otherwisecarried by one or both of the first substrate 802, the adhesive layer815, and/or the piece of absorbent material, gauze or sponge 804.However, in other implementations, at least a portion of the passiveantenna element 814 is embedded within or forms a portion of the firstsubstrate 802 or the piece of absorbent material, gauze or sponge 804 orother medical procedure object (e.g., medical instrument, tool).

In yet further implementations, the respective positions of the activeantenna element 808 and the passive antenna element 814 may be oppositeto those depicted in FIG. 8. That is, the passive antenna element 814may be adhered to or carried by a surface of the first substrate 802that is opposite the piece of absorbent material, gauze or sponge 804while the active antenna element 808 is positioned between the firstsubstrate 802 and the piece of absorbent material, gauze or sponge 804.

While FIG. 8 depicts first substrate 802 as not contacting the piece ofabsorbent material, gauze or sponge 804 or the adhesive layer 815, insome implementations, the first substrate 802 is directly physicallycoupled to (e.g., by an heat or RF weld) the piece of absorbentmaterial, gauze or sponge 804. Further, in some implementations, thepresence dumb transponder 812 is omitted.

All of the materials that form the attachment structure 800, as well asthe presence or dumb transponder 812 and the RFID transponder 806 mayretain their structural and functional integrity when exposed toelevated temperatures and/or pressures and/or ionizing radiation dosagescommonly employed during sterilization of objects to be used in medicalapplications, such as clinical or surgical procedures, as previouslyspecified herein. One or more components or structures may be protectedor shielded, for instance by an encapsulant that retains its structuraland functional integrity when exposed to elevated temperatures and/orpressures and/or ionizing radiation dosages commonly employed duringsterilization of objects to be used in medical applications, such asclinical or surgical procedures, as previously specified herein.

FIG. 9 shows an attachment structure 900 that carries at least onewireless transponder (e.g., presence or dumb transponder 910, RFIDtransponder 906) and optionally a directional antenna carried at leastin part by a first substrate 902, according to one illustratedembodiment.

The attachment structure 900 is physically coupled to a medicalprocedure object, for instance a piece of absorbent material, gauze orsponge 916. The attachment structure 900 may, for example, include anadhesive layer 915, which may be positioned between and respectivelyphysically coupled to the remainder of the attachment structure 900 andthe piece of absorbent material, gauze or sponge 916. However, in someimplementations, the attachment structure 900 does not include theadhesive layer 915.

An RFID transponder 906 and a presence or dumb transponder 910 arephysically coupled to the first substrate 902 of the attachmentstructure 900. The attachment structure 900 further includes a secondsubstrate 904. The first substrate 902 and/or the second substrate 904may be flexible layers. For example, the first substrate 902 and/or thesecond substrate 904 may be the same as or similar to layers 208 and 210discussed with reference to FIG. 2A. The adhesive layer 915 may be thesame as or similar to adhesive layer 212 discussed with reference toFIG. 2A.

The RFID transponder 906 includes an active antenna element 908 and anintegrated circuit 910. For example, the integrated circuit 910 mayselectively actively energize or otherwise cause the active antennaelement 908 to radiate to transmit a signal. The attachment structure900 optionally carries or holds one or more passive antenna elements 914(only one shown) that, together with the active antenna element 908,operates as a directional antenna. For example, the passive antennaelement 914 and the active antenna element 908 may together operate as aYagi antenna.

As shown in FIG. 9, the passive antenna element 914 is positionedbetween the first substrate 902 and the second substrate 904. Forexample, the passive antenna element 914 can be adhered to, printed,deposited or otherwise formed onto, or otherwise carried by one or bothof the first substrate 902 and/or the second substrate 904. However, inother implementations, at least a portion of the passive antenna element914 is embedded within or forms a portion of the first substrate 902 orthe second substrate 904.

In yet further implementations, the respective positions of the activeantenna element 908 and the passive antenna element 914 may be oppositeto those depicted in FIG. 9. That is, the passive antenna element 914may be adhered to or carried by a surface of the first substrate 902that is opposite the second substrate 904 while the active antennaelement 908 is positioned between the first substrate 902 and the secondsubstrate 904. Further, in some implementations, one or more heat or RFwelds or other securement structures (e.g., adhesive layer 915,stitches, staples) physically couple one or both of the first and secondsubstrates 902 and 904 to the piece of absorbent material, gauze, sponge916 or other medical procedure object which are used to perform medicalprocedures.

Furthermore, while FIG. 9 depicts first substrate 802 as not directlycontacting the second substrate 904, in some implementations, the firstsubstrate 902 is directly physically coupled to (e.g., by a heat or RFweld) the second substrate 904. Likewise, a heat or RF weld mayphysically couple the second substrate 904 to the piece of absorbentmaterial, gauze or sponge 916 or other medical procedure object.Further, in some implementations, the presence or dumb transponder 910is omitted.

All of the materials that form the attachment structure 900, as well asthe presence or dumb transponder 910 and the RFID transponder 906 mayretain their structural and functional integrity when exposed toelevated temperatures and/or pressures and/or ionizing radiation dosagescommonly employed during sterilization of objects to be used in medicalapplications, such as clinical or surgical procedures, as previouslyspecified herein. One or more components or structures may be protectedor shielded, for instance by an encapsulant that retains its structuraland functional integrity when exposed to elevated temperatures and/orpressures and/or ionizing radiation dosages commonly employed duringsterilization of objects to be used in medical applications, such asclinical or surgical procedures, as previously specified herein.

FIG. 10 a manufacturing system 1000 to manufacture wirelessly detectablemedical procedure objects using heat or RF welding, according to oneillustrated embodiment.

In particular, the system 1000 may provide a web of first flexible layermaterial 1002 from a spool of first flexible layer material; a web ofsecond flexible layer material 1006 from a spool of second flexiblelayer material; and a web of adhesive layer material 1004 from a spoolof adhesive layer material. For example, either or both of the firstflexible layer 1002 and the second flexible layer 1006 may be the sameas or similar to layers 208 and 210 discussed with reference to FIG. 2A.The adhesive layer 1004 may be the same as or similar to adhesive layer212 of FIG. 2A. In some implementations, as shown in FIG. 10, the firstand/or second flexible layers 1002 and 1006 and/or adhesive layermaterial 1004 may be provided as rolls or spools of material, oralternatively as sheets of flexible layers. Alternatively, the adhesivelayer material 1004 may be provided as a liquid or gel, and sprayed,printed, painted, deposited or otherwise applied. Further, in someimplementations, a roll of absorbent material or gauze to fabricatesponges (not shown in FIG. 10) may also be provided.

The system 1000 may include a welder, welding unit or welding machine1008 to heat or RF weld the first flexible layer 1002 to the secondflexible layer 1006 to form a plurality of pouches (e.g., pouches 1012 aand 1012 b). The adhesive layer 1004 may be physically coupled (e.g., byRF welding or other techniques or via adhesion due to the adhesiveproperty of the adhesive layer 1004) to at least the second flexiblelayer 1006 opposite the first flexible layer 1002.

Each of the plurality of pouches can be formed by a set of heat or RFwelds. For example, welding machine 1008 (e.g., heat or RF weldingmachine) can be used to create a plurality of heat or RF welds thatphysically couple the first flexible layer 1002 to the second flexiblelayer 1006 and create the plurality of pouches 1012 a and 1012 b. Eachset of heat or RF welds can take the form of a hollowed rectangle,circle, oval, or other shape to form an interior cavity within aperimeter of the hollowed area. One or more transponders can be sealedwithin the interior cavity (not illustrated in FIG. 10) of each pouch1012.

Thus, through autonomous or automatic or manual operation of the RFwelding machine 1008 to generate the plurality of heat or RF welds, thefirst and second flexible layers 1002 and 1006 are transformed into asheet or roll of pouches 1010, with each pouch 1012 retaining one ormore wireless transponders. As such, rather than being discretely madefrom the assembly of individual components, web based media andcontinuous web manufacturing techniques may fabricate the pouches 1012as a continuous web and hence a roll of pouches 1010, each pouch 1012containing one or more respective wireless transponders. Employing webmedia based techniques enhances the efficiency in the manufacturingprocess, as all that remains to be done is cutting or separating thepouches 1012 from the roll 1010 and attaching each of the pouches 1012to a respective surgical object (e.g., via adhesive layer 1004).

FIG. 11 shows flexible layers usable to manufacture a plurality ofpouches, according to one illustrated embodiment.

In particular, FIG. 11 shows a first flexible layer 1104 of nylon; asecond flexible layer 1102 of thermoplastic polyurethane; and anadhesive layer 1106. The above noted materials are provided as examplesonly. In particular, the flexible layers 1104 and 1102 may be the sameas or similar to layers 208 and 210 discussed with reference to FIG. 2A.

All of the materials that form the pouches of FIG. 11, as well as thepresence or dumb transponder and the RFID transponder retained orcarried thereby, may retain their structural and functional integritywhen exposed to elevated temperatures and/or pressures and/or ionizingradiation dosages commonly employed during sterilization of objects tobe used in medical applications, such as clinical or surgicalprocedures, as previously specified herein.

FIG. 12 shows manufacture of a plurality of pouches using an RF or heatwelding technique, according to one illustrated embodiment.

In particular, FIG. 12 shows the first flexible layer 1204 of nylon; thesecond flexible layer 1202 of thermoplastic polyurethane; and theadhesive layer 1206. An RF or heat welding machine 1210 is used togenerate a plurality of RF welds to physically couple layer 1102 tolayer 1104 and/or adhesive layer 1206 and form a plurality of pouches.As an example, an RF or heat weld 1214 forms at least a portion of aperimeter of an interior cavity of an unfinished pouch 1212. One or moretransponders (not shown) may be positioned between layers 1102 and 1104and then sealed within the pouch 1212 by an additional RF or heat weld.

As one example method of manufacture, the pouches may be made by RF orheat welding the first layer 1204 to the second layer 1202 where aseries of cavities for receiving one or more corresponding transpondersare made by providing bulges in the first layer 1204 and/or the secondlayer 1202. The bulges may be formed by bunching or stretching thematerial of the first layer 1204 and/or the second layer 1202.

FIG. 13 a web 1300 of a plurality of pouches 1302, 1304, and 1306manufactured using the RF or heat welding technique illustrated in FIGS.10 and 12, according to one illustrated embodiment. In particular, aplurality of RF or heat welds form each of pouches 1302, 1304, and 1306.For example, RF or heat welds 1308 and 1310 form at least a portion of aperimeter of an interior cavity of pouch 1304. A presence or dumbtransponder 1312 is received and freely movable within the interiorcavity 1301 of pouch 1304. Pouches 1302 and 1306 are bisected for thepurposes of illustration. The pouches 1302, 1304, and 1306 may bephysically separated (e.g., cut apart) and then respectively physicallycoupled to surgical objects to act as wirelessly detectable objects(e.g., via use of an adhesive layer).

FIGS. 14A-14E sequentially show a piece of gauze 1400 being folded froma pre-folded configuration into a folded configuration as a sponge 1401(FIGS. 14D, 14E), according to at least one illustrated embodiment. Inthe particular folded configuration illustrated, the sponge 1401 mayadvantageously be easier to detect and/or distinguish from neighboringsponges in a set, packet or package of sponges, using imagingtechniques, described herein, due to the resulting orientation and/orspacing of radio-opaque material 1422, 1424 and/or wireless transponder1426 in a pouch 1428.

FIG. 14A shows a piece of absorbent material or gauze 1400 similar oreven identical to those previously described and illustrated, with firstand second radio-opaque material 1422, 1424 and a wireless transponder1426.

All of the materials that form the wireless transponder 1426 (e.g.,presence or dumb transponder and the RFID transponder) and/or whichretain the wireless transponder 1426 to the piece of absorbent materialor gauze 1400, may retain their structural and functional integrity whenexposed to elevated temperatures and/or pressures and/or ionizingradiation dosages commonly employed during sterilization of objects tobe used in medical applications, such as clinical or surgicalprocedures, as previously specified herein.

Notably, the first and second radio-opaque material 1422, 1424 arepositioned on a same half of the piece of gauze 1400 with respect to alongitudinal middle or center of the piece of gauze 1400 (i.e., middlealong the longitudinal axis as the piece of gauze lies flat). Asillustrated by arrow 1402 in FIG. 14A, a first portion or panel of thepiece of gauze 1400 is folded across a first fold-line 1404 such thattwo resulting portions of the first major face 1414 are broughttogether, facing one another. In some implementations, ends of the pieceof gauze 1400 opposed to one another along a length of the piece ofgauze 1400 may each be folded over itself, and stitched or otherwisesecured before the folding of the piece of gauze 1400 into a sponge.This may reduce the chance of stray material or fibers from separatingfrom the piece of gauze 1400.

FIG. 14B shows the piece of gauze 1400 of FIG. 14A folded across thefirst fold-line 1404, one half of the piece of gauze 1400 overlying theother half of the piece of gauze 1400. As illustrated in FIG. 14B, thesecond major face 1416 is on an exterior the partially folded piece ofgauze 1400, while the first major face 1414 is now on an interior of thepartially folded piece of gauze 1400. Notably, the first and secondradio-opaque material 1422, 1424 are positioned on respective halves ofthe partially folded piece of gauze 1400 with respect to a longitudinalmiddle or center of the partially folded piece of gauze 1400.

As illustrated by arrow 1406 in FIG. 14C, the piece of gauze 1400 isfolded across a second fold-line 1408 such that the two halves of thefirst major face 1414 of the partially folded piece of gauze 1400 arebrought together, facing one another.

FIGS. 14D and 14E show the piece of gauze 1400 of FIG. 14C folded acrossthe second fold-line 1404 in a folded configuration, four portions ofthe piece of gauze 1400 overlying one another. Notably, the radio-opaquematerial 1422, 1424 is carried by respective inner pieces or panels 310,312 of the piece of gauze 1400 or sponge 1401, with respect to a pair ofouter pieces or panels 314, 316 of the piece of gauze 1400 or sponge1401. As best seen in FIG. 14E, the sponge 1401 includes two folds andresults in four pieces or panels overlying one another, in a nestedconfiguration, with the radio-opaque material 1422, 1424 spacedrelatively inward of the outer most panels or pieces 314, 316 and ondistinctly panels or pieces 310, 312 from one another, advantageouslyenhancing detectability using imaging techniques. Further, thetransponder 1426 may overlie one of the radio-opaque material 1422, 1424when viewed from a resulting major face of the sponge 1401,advantageously enhancing detectability.

For example, the piece of gauze 1400 may be folded once, i.e., into twopanels, which may be denominated as a V-fold. The piece of gauze 1400may be folded twice, i.e., into three panels. There are two possibleconfigurations for three panels, A first configuration is denominated asa Z-fold, which sandwiches a middle panel (i.e., middle along a lengthof the piece of gauze 1400) between two end panels (i.e., ends along thelength of the piece of gauze 1400). A second configuration isdenominated as a C-fold, in which one of the end panels (i.e., end alonga length of the piece of gauze 1400) is sandwiched between the other endpanel and the middle panel (i.e., middle along a length of the piece ofgauze 1400).

FIGS. 15A and 15B show an apparatus 1500 to physically couple at leastone wireless transponder (e.g., RFID transponder 1537, presence or dumbtransponder 1538) to a medical procedure object, for instance aninstrument 1590. In particular, FIG. 15A shows the apparatus 1500 notphysically coupled to the medical procedure object 1590 while FIG. 15Bshows the apparatus 1500 physically coupled to the medical procedureobject 1590.

As illustrated, the apparatus 1500 may physically couple both an RFIDtransponder 1537 and a presence or dumb transponder 1538 to a medicalprocedure object, for instance instrument 1590. The RFID transponder1537 may be formed as a flexible tag, employing a flexible substrate1539 (e.g. relatively few layers of FR4) which carries an RFIDintegrated circuit 1541 and antenna 1543 (e.g. electrically conductivetrace) communicatively coupled to the RFID integrated circuit 1541. TheRFID transponder 1537 may be physically coupled to the presence or dumbtransponder 1538. For example, the RFID transponder 1537 may at leastpartially wrap about an exterior periphery or exterior surface 1547 ofthe presence or dumb transponder 1538. The RFID transponder 1537 may beattached to the presence or dumb transponder 1538 via an adhesive or maybe retained thereto under pressure.

All of the materials that form the wireless transponders (e.g., RFIDtransponder 1537, presence or dumb transponder 1538) and/or whichattaches the RFID transponder 1537 to the presence or dumb transponder1538, may retain their structural and functional integrity when exposedto elevated temperatures and/or pressures and/or ionizing radiationdosages commonly employed during sterilization of objects to be used inmedical applications, such as clinical or surgical procedures, aspreviously specified herein.

The apparatus 1500 includes a first clamp 1502, a second clamp 1552, anda housing 1530. The housing 1530 is transparently depicted for thepurposes of illustrating certain features of the apparatus 1500 internalto the housing 1530. However, the housing 1530 is typically nottransparent.

The first clamp 1502 includes a first fastener 1504 and a first channelmember 1506. The first channel member 1506 has a first base 1508 and afirst pair of side portions 1510 a and 1510 b that extend from the firstbase 1508. The first pair of side portions 1510 a and 1510 b are opposedto one another across a width 1512 of the first channel member 1506 toform a first channel 1514 therebetween. The width 1512 of the firstchannel 1514 is sized to receive at least a first portion 1592 of themedical procedure object 1590 therein.

The first channel member 1506 may be metal, plastic, and/or othermaterials. The first channel member 1506 may be a single integral pieceor may be formed from multiple components. For example, one or morebending operations may shape a single band of metal into the firstchannel member 1506. Alternatively, the first pair of side portions 1510a and 1510 b may be separate pieces that are physically coupled to thefirst base 1508 (e.g., by welding).

As shown best in FIG. 15A, the first base 1508 is curved to accommodatea curved surface of the medical procedure object 1590 (e.g., a curvedsurface of an elongated handle portion or elongated member of themedical procedure object 1590). In some implementations, the first sideportions 1510 a and 1510 b are similarly curved to accommodate a portionof the medical procedure object 1590 with multiple curved surfaces(e.g., a cylindrical portion). However, in some implementations, neitherthe first base 1508 nor the first side portions 1510 a and 1510 b arecurved, thereby accommodating a portion of the medical procedure object1590 with a rectangular cross-section.

Similar to first clamp 1502, the second clamp 1552 includes a secondfastener 1554 and a second channel member 1556. The second channelmember 1556 has a second base 1558 and a second pair of side portions1560 a and 1560 b that extend from the second base 158. The second pairof side portions 1560 a and 1560 b are opposed to one another across awidth 1562 of the second channel member 1556 to form a second channel1564 therebetween. The width 1562 of the second channel 1564 is sized toreceive at least a second portion 1594 of the medical procedure object1590 therein. The second channel member 1556 may be constructed asdiscussed above with respect to the first channel member 1506.

The housing 1530 has a first cavity 1532, a second cavity 1540, a firstpassageway 1534, a second passageway 1536, and a third passageway 1542.The first cavity 1532 receives at least a portion of the first pair ofside portions 1510 a and 1510 b of the first channel member 1506. Thesecond cavity 1540 receives at least a portion of the second pair ofside portions 1560 a and 1560 b of the second channel member 1556.

The housing 1530 may be non-metallic (e.g., formed of one or moreplastics) to prevent the housing 1530 from impeding or interfering withaccurate detection of the transponder 1538 by the detection andinterrogation system 5. In some implementations, the housing 1530 is asingle, integral piece of plastic formed through a molding process. Forexample, the passageways 1534, 1536, and 1542 may be defined within thehousing 1530 during the molding process. Alternatively, one or moredrilling operations may create the passageways 134, 1536, and 1542 inthe single, integral piece of plastic. In other implementations, thehousing 130 comprises two or more portions that are secured togetherafter manufacturing. For example, the housing 1530 may consist of twobody portions that snap together or otherwise have means for coupling toeach other (e.g., a complementary peg and hole, clasps, etc.). Thehousing 1530 may be rigid and non-elastic or may exhibit someelasticity.

The housing 1530 may retain its structural and functional integrity whenexposed to elevated temperatures and/or pressures and/or ionizingradiation dosages commonly employed during sterilization of objects tobe used in medical applications, such as clinical or surgicalprocedures, as previously specified herein.

As shown best in FIG. 15A, the first passageway 1534 extends in a firstdirection, the second passageway 1536 extends in a second direction, andthe third passageway 1542 extends in a third direction. The thirddirection is parallel to the first direction and the second direction isnot parallel to the first and the third directions. In someimplementations, the second direction is substantially perpendicular tothe first and third directions.

The first passageway 1534 receives the first fastener 1504. The firstpassageway 1534 opens at least in part into the first cavity 1532 topermit the first fastener 1504 to extend at least in part into the firstcavity 1532 and adjustably engage with the first channel member 1506. Inparticular, the first fastener 1504 includes a first screw that has ahead 1518 and an elongated shaft 1516. The shaft 1516 has a firstdiameter and the head 1518 has a second diameter that is greater thanthe first diameter. The first passageway 1534 includes an outer portionthat has a third diameter that is greater than the second diameter andan inner portion that has a fourth diameter that is greater than thefirst diameter and less than the second diameter. As such, the firstpassageway 1534 defines a first shelf at a first transition between theouter portion and the inner portion of the first passageway 1534. Thehead 1518 of the first screw engages the first shelf.

The first fastener 1504 adjustably engages with the first channel member1506 to securingly clamp the first portion 1592 of the medical procedureobject 190 in the first channel 114 of the first channel member 1506.More particularly, the shaft 1516 has external threading. The firstfastener 1504 further includes a first nut 1520 that securingly receivesthe shaft 1516 (e.g., has internal threading complementary to theexternal threading of the shaft 1516). The first channel member 106further includes a first pair of flanges 1522 a and 1522 b thatrespectively extend from the first pair of side portions 1510 a and 1510b into the first channel 1514. The first nut 1520 is positioned betweenthe first pair of flanges 1522 a and 1522 b and the first base 1508. Thefirst nut 1520 physically engages the first pair of flanges 1522 a and1522 b.

Alternatively, a twist tie may be used, for example as a wire or metalsuture where the twist tie replaces the channel member and the fastener.In particular, a wire or metal suture may form a loop through which aportion of the instrument 1590 is received, and the end portions of thewire or metal suture are twisted together to secure the housing 1530 tothe instrument 1590. Such is illustrated in U.S. provisional patentapplication Ser. No. 62/138,248.

Thus, for example, the shaft 1516 extends from the first passageway 1534into the first cavity 1532 to securingly and adjustably engage with thefirst nut 1520. The first nut 1520 physically engages the first pair offlanges 1522 a and 1522 b. Rotation of the first screw in a firstrotational direction will therefore result in the first clamp 1502 beingtightened to securingly clamp the first portion 192 of the medicalprocedure object 190 in the first channel 1514. Likewise, rotation ofthe first screw in a second rotational direction opposite the first willresult in the first clamp 1502 being loosened.

The third passageway 1542 receives the second fastener 1554 and opens atleast in part into the second cavity 1540 to permit the second fastener1554 to extend at least in part into the second cavity 1540 andadjustably engage with the second channel member 1556. In particular,the second fastener 1554 includes a second screw that has a head 1568and an elongated shaft 1566. The shaft 166 has the first diameter andthe head 1568 has the second diameter that is greater than the seconddiameter. The second passageway 1542 includes an outer portion that hasthe third diameter that is greater than the second diameter and an innerportion that has the fourth diameter that is greater than the firstdiameter and less than the second diameter. As such, the secondpassageway 1542 defines a second shelf at a second transition betweenthe outer portion and the inner portion of the second passageway 1542.The head 1568 of the second screw engages the second shelf.

The second fastener 1554 adjustably engages with the second channelmember 1556 to securingly clamp the second portion 1594 of the medicalprocedure object 1590 in the second channel 1564 of the second channelmember 1556. More particularly, the shaft 166 has external threading andthe second fastener 1554 further includes a second nut 1570 thatsecuringly receives the shaft 1566 (e.g., has internal threadingcomplementary to the external threading of the shaft 1566). The secondchannel member 1556 further includes a second pair of flanges 1572 a and1572 b that respectively extend from the second pair of side portions1560 a and 1560 b into the second channel 1564. The second nut 170 ispositioned between the second pair of flanges 1572 a and 1572 b and thesecond base 1558. The second nut 1570 physically engages the second pairof flanges 1572 a and 1572 b.

Thus, for example, the shaft 1566 extends from the second passageway1542 into the second cavity 1540 to securingly and adjustably engagewith the second nut 1570. The second nut 1570 physically engages thesecond pair of flanges 1572 a and 1572 b. Rotation of the second screwin a first rotational direction will therefore result in the secondclamp 1552 being tightened to securingly clamp the second portion 194 ofthe medical procedure object 1590 in the second channel 1564. Likewise,rotation of the second screw in a second rotational direction oppositethe first will result in the second clamp 1552 being loosened.

The second passageway 1536 receives at least one wireless transponder1537, 1538 that wirelessly receives and returns signals. The wirelesstransponder 1537, 1538 may be constructed in various manners. Forexample, an LC resonant or dumb transponder 1538 may include a ferriterod with a conductive coil wrapped about an exterior surface thereof toform an inductor, and a capacitor coupled to the conductive coil to forma series circuit. The conductive coil may, for example, take the form ofa spiral wound conductive wire with an electrically insulative sheath orsleeve. In other implementations, an RFID transponder 1537 includes anRFID chip 1541 that stores identification information that uniquelyidentifies the transponder 1537. Additional details about types oftransponders may be found in U.S. Provisional Patent Application No.60/811,376 filed Jun. 6, 2006; U.S. Provisional Patent Application No.60/892,208 filed Feb. 28, 2007; and U.S. Provisional Patent ApplicationNo. 62/106,052 filed Jan. 21, 2015, each of which are hereinincorporated by reference.

The second passageway 1536 intersects the first passageway 1534. Inparticular, the second passageway 1536 intersects the outer portion ofthe first passageway 1534. The second passageway 136 has a fifthdiameter at least greater than the second diameter of the head 1518 ofthe first fastener 1504.

In some implementations, an encapsulant (not shown) fills the portionsof each of passageways 1534, 1536, and 1542 that are respectivelyunoccupied by the first fastener 1504, the transponder 1538, and thesecond fastener 1554. The encapsulant may be shaped to substantiallymatch an exterior surface of the housing 1530 and thereby contribute toa substantially continuous exterior surface of the apparatus 1500. Theencapsulant may ensure that the first fastener 1504, the transponder1538, and the second fastener 1554 are physically secured in theirrespective positions and/or prevent contaminants from entering thepassageways 1534, 1536, and 1542.

In some implementations, the encapsulant is capable of withstandingmultiple rounds of sterilization of the apparatus 100 by one or more ofautoclaving, electron beam or isotope radiation, ethylene oxide, plasmaor corona discharge, and liquid sterilants. In some implementations, theencapsulant is a biocompatible epoxy. In some implementations, theencapsulant may be readily removed from at least passageways 1534 and1542 to permit removal of the apparatus 1500 from the instrument 1590.For example, the encapsulant may be removed via drilling or mechanicalabrasion.

The housing 1530 is preferably transparent to electromagnetic energy atleast in the wavelengths at which the wireless transponders 1537, 1538operate.

Furthermore, in some implementations, the apparatus 1500 is manufacturedand distributed without a transponder 1538 attached or received withinthe housing 1530. Advantageously, a transponder 1538 compatible with aparticular detection and interrogation system can be placed into theapparatus 1500 at a subsequent time, for example by the end-user.

The above description of illustrated embodiments, including what isdescribed in the Abstract, is not intended to be exhaustive or to limitthe various embodiments to the precise forms disclosed. Althoughspecific embodiments of and examples are described herein forillustrative purposes, various equivalent modifications can be madewithout departing from the spirit and scope of the disclosure, as willbe recognized by those skilled in the relevant art.

The teachings provided herein can be applied to other absorbentmaterials, other types of transponders, and other interrogation anddetection systems. For instance, the transponder device may be used tomark objects anytime detection of the presence of marked objects isdesirable in a confined area, not just during surgery. For example, itmay be used to make sure marked objects are not left inside a machine(e.g., vehicle, copy machine) after maintenance is performed. In atleast some embodiments, the transponder housing may be utilized to markobjects to determine the removal of a marked object from a confinedarea, such as a cover-all garment from a clean room of a semiconductorfabrication plant. In such an embodiment, an interrogation device, forexample, may be placed proximate to a door of the confined area.

In addition, a transponder pouch may be manufactured and distributed fortagging objects without a transponder currently attached or receivedtherein. Advantageously, the pouch can then be used to place atransponder compatible with a particular detection and interrogationsystem at a subsequent time, including by the end-user.

The various embodiments described above can be combined to providefurther embodiments. To the extent that they are not inconsistent withthe specific teachings and definitions herein, all of the commonlyassigned U.S. patents, U.S. patent application publications, U.S. patentapplications referred to in this specification, including but notlimited to U.S. Pat. No. 8,358,212; U.S. Pat. No. 8,710,957; U.S. Pat.No. 8,726,911; U.S. Patent Application Publication No. 2010/0108079;U.S. Provisional Patent Application Ser. No. 60/811,376 filed Jun. 6,2006; U.S. Provisional Patent Application Ser. No. 60/892,208, filedFeb. 28, 2007; U.S. Provisional Patent Application Ser. No. 61/109,142filed Oct. 28, 2008; U.S. Provisional Patent Application Ser. No.62/106,052 filed Jan. 21, 2015; U.S. Provisional Patent Application Ser.No. 62/121,358 filed Feb. 26, 2015; U.S. Provisional Patent ApplicationSer. No. 62/138,248 filed Mar. 25, 2015; U.S. Provisional PatentApplication Ser. No. 62/143,726 filed Apr. 6, 2015; U.S. ProvisionalPatent Application Ser. No. 62/164,412 filed May 20, 2015; and U.S.Provisional Patent Application Ser. No. 62/182,294 filed Jun. 19, 2015are each incorporated herein by reference, in their entirety. Aspects ofthe embodiments can be modified, if necessary, to employ systems,circuits and concepts of the various patents, applications andpublications to provide yet further embodiments.

These and other changes can be made in light of the above-detaileddescription. In general, in the following claims, the terms used shouldnot be construed to limit the invention to the specific embodimentsdisclosed in the specification and the claims, but should be construedto include all possible embodiments along with the full scope ofequivalents to which such claims are entitled. Accordingly, theinvention is not limited by the disclosure.

What is claimed is:
 1. A wirelessly detectable object to use in medicalprocedures, comprising: a medical procedure object for use in performinga medical procedure, wherein the medical procedure object is a sponge; aradiation hard read only radio frequency identification (RFID)transponder that wirelessly receives a first interrogation signal and inresponse wirelessly returns a first response signal that provides aunique identifier, wherein the RFID transponder includes a flexiblesubstrate, the flexible substrate forms a portion of a pouch that isattached to the sponge via at least one of a stitch, a weld or anadhesive which retains structural and functional integrity at least attemperatures equal to 121 degrees Centigrade, 130 degrees Centigrade,136 degrees Centigrade, or 150 degrees Centigrade at pressures of atleast 1 atmosphere or higher and which retains structural and functionalintegrity at least at ionizing radiation dosages of betweenapproximately 8 and 15 kGy, or between approximately 25 and 40 kGy, orbetween approximately 50 and 100 kGy, for from approximately 1 minute to12 minutes; and an attachment structure that attaches the radiation hardread only RFID transponder to the medical procedure object.
 2. Thewirelessly detectable object of claim 1 wherein the attachment structurecomprises at least one piece of material, the at least one piece ofmaterial attached to the sponge via at least one stitch which retainsstructural and functional integrity at least at temperatures equal to121 degrees Centigrade, 130 degrees Centigrade, 136 degrees Centigrade,or 150 degrees Centigrade at pressures of at least 1 atmosphere orhigher.
 3. The wirelessly detectable object of claim 1 wherein theattachment structure comprises at least one piece of material, the atleast one piece of material attached to the sponge via at least one weldwhich retains structural and functional integrity at least attemperatures equal to 121 degrees Centigrade, 130 degrees Centigrade,136 degrees Centigrade, or 150 degrees Centigrade at pressures of atleast 1 atmosphere or higher.
 4. The wirelessly detectable object ofclaim 1 wherein the attachment structure comprises at least one piece ofmaterial, the at least one piece of material attached to the sponge viaan adhesive which retains structural and functional integrity at leastat temperatures equal to 121 degrees Centigrade, 130 degrees Centigrade,136 degrees Centigrade, or 150 degrees Centigrade at pressures of atleast 1 atmosphere or higher and which retains structural and functionalintegrity at least at ionizing radiation dosages of betweenapproximately 8 and 15 kGy, or between approximately 25 and 40 kGy, orbetween approximately 50 and 100 kGy, for from approximately 1 minute to12 minutes.
 5. The wirelessly detectable object of claim 1 wherein theattachment structure comprises at least one piece of material that formsa pouch, having an interior cavity.
 6. The wirelessly detectable objectof claim 5 wherein the RFID transponder is received within the interiorcavity of the pouch and the secured therein.
 7. The wirelesslydetectable object of claim 5 wherein the RFID transponder is receivedwithin the interior cavity and secured therein via one of stitches or aweld about at least a portion of a perimeter of the pouch which retainsstructural and functional integrity at least at temperatures equal to121 degrees Centigrade, 130 degrees Centigrade, 136 degrees Centigrade,or 150 degrees Centigrade at pressures of at least 1 atmosphere orhigher and which retains structural and functional integrity at least ationizing radiation dosages of between approximately 8 and 15 kGy, orbetween approximately 25 and 40 kGy, or between approximately 50 and 100kGy, for from approximately 1 minute to 12 minutes.
 8. The wirelesslydetectable object of claim 6 wherein the pouch is attached to the spongevia at least one stitch which retains structural and functionalintegrity at least at temperatures equal to 121 degrees Centigrade, 130degrees Centigrade, 136 degrees Centigrade, or 150 degrees Centigrade atpressures of at least 1 atmosphere or higher and which retainsstructural and functional integrity at least at ionizing radiationdosages of between approximately 8 and 15 kGy, or between approximately25 and 40 kGy, or between approximately 50 and 100 kGy, for fromapproximately 1 minute to 12 minutes.
 9. The wirelessly detectableobject of claim 6 wherein the pouch is attached to the sponge via atleast one of a heat weld or a radio frequency (RF) weld which retainsstructural and functional integrity at least at temperatures equal to121 degrees Centigrade, 130 degrees Centigrade, 136 degrees Centigrade,or 150 degrees Centigrade at pressures of at least 1 atmosphere orhigher and which retains structural and functional integrity at least ationizing radiation dosages of between approximately 8 and 15 kGy, orbetween approximately 25 and 40 kGy, or between approximately 50 and 100kGy, for from approximately 1 minute to 12 minutes.
 10. The wirelesslydetectable object of claim 6 wherein the pouch is attached to the spongevia at least an adhesive which retains structural and functionalintegrity at least at temperatures equal to 121 degrees Centigrade, 130degrees Centigrade, 136 degrees Centigrade, or 150 degrees Centigrade atpressures of at least 1 atmosphere or higher and which retainsstructural and functional integrity at least at ionizing radiationdosages of between approximately 8 and 15 kGy, or between approximately25 and 40 kGy, or between approximately 50 and 100 kGy, for fromapproximately 1 minute to 12 minutes.
 11. The wirelessly detectableobject of claim 5 wherein the RFID transponder is received and freelymovable within the interior cavity of the pouch.
 12. The wirelesslydetectable object of claim 5 wherein the at least one piece of materialthe forms the pouch comprises a fabric laminate that comprises at leastone of a thermoplastic polyurethane and nylon fabric or polyvinylchloride (PVC) impregnated fabric which retains structural andfunctional integrity at least at temperatures equal to 121 degreesCentigrade, 130 degrees Centigrade, 136 degrees Centigrade, or 150degrees Centigrade at pressures of at least 1 atmosphere or higher andwhich retains structural and functional integrity at least at ionizingradiation dosages of between approximately 8 and 15 kGy, or betweenapproximately 25 and 40 kGy, or between approximately 50 and 100 kGy,for from approximately 1 minute to 12 minutes.
 13. A wirelesslydetectable object to use in medical procedures, comprising: a medicalprocedure object for use in performing a medical procedure, wherein themedical procedure object is a sponge, wherein the sponge includes a pairof outer-most fold portions and at least two inner fold portions, theinner fold portions spaced inwardly from and between the outer-most foldportions; a first piece of radio-opaque material extending along a widthof the sponge; a second piece of radio-opaque material extending alongthe width of the sponge and spaced from the first radio-opaque material,wherein the first and the second pieces of radio-opaque material arecarried by the inner fold portions; a radiation hard read only radiofrequency identification (RFID) transponder that wirelessly receives afirst interrogation signal and in response wirelessly returns a firstresponse signal that provides a unique identifier; and an attachmentstructure that attaches the radiation hard read only RFID transponder tothe medical procedure object.
 14. The wirelessly detectable object ofclaim 1 wherein the RFID transponder comprises a radiation hard RFIDintegrated circuit and an antenna trace, the antenna tracecommunicatively coupled to the radiation hard RFID integrated circuit,and the radiation hard RFID integrated circuit retains structural andfunctional integrity at least at ionizing radiation dosages of betweenapproximately 8 and 15 kGy, or between approximately 25 and 40 kGy, orbetween approximately 50 and 100 kGy, for from approximately 1 minute to12 minutes.
 15. The wirelessly detectable object of claim 14, furthercomprising: a passive antenna element attached to the sponge, thepassive antenna element positioned to communicatively couple to theantenna trace to form a directional antenna.
 16. The wirelesslydetectable object of claim 1 wherein the RFID transponder comprises anRFID integrated circuit, an antenna trace, and a radiation hardeningencapsulant, the antenna trace communicatively coupled to the RFIDintegrated circuit, and the RFID integrated circuit encapsulated by theradiation hardening encapsulant, and the radiation hardening encapsulantcauses the RFID integrated circuit to retain structural and functionalintegrity at least at ionizing radiation dosages of betweenapproximately 8 and 15 kGy, or between approximately 25 and 40 kGy, orbetween approximately 50 and 100 kGy, for from approximately 1 minute to12 minutes.
 17. The wirelessly detectable object of claim 1, furthercomprising: a dumb transponder that in response to wirelessinterrogation, wirelessly returns a second response signal that does notcontain identification information, the dumb transponder attached to thesponge, the dumb transponder which retains structural and functionalintegrity at least at ionizing radiation dosages of betweenapproximately 8 and 15 kGy, or between approximately 25 and 40 kGy, orbetween approximately 50 and 100 kGy, for from approximately 1 minute to12 minutes.